Apparatus and Method for Minimally Invasive Suturing

ABSTRACT

An apparatus and method for minimally invasive suturing is disclosed. A suturing device for minimally invasive suturing includes proximal section having a proximal end, a distal end, and a longitudinal axis therebetween; a suture head assembly extending from the distal end of the proximal section; a suturing needle having a pointed end and a blunt end, the suturing needle capable of rotating about an axis approximately perpendicular to a longitudinal axis of the proximal section, wherein the pointed end of the suturing needle is positioned within the suture head assembly prior to and after rotation of the suturing needle; and an actuator extending from the proximal end of the proximal section to actuate a drive mechanism having a needle driver for engaging and rotating the suturing needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of Ser. No. 13/361,444 filed Jan. 30,2012, which is a Continuation of application Ser. No. 12/592,174 filedon Nov. 20, 2009, which claims the benefit of priority to U.S.Provisional Application 61/200,180 filed on Nov. 25, 2008. ApplicationSer. No. 12/592,174 is a Continuation-in-part of application Ser. No.11/231,135 filed on Sep. 20, 2005, now U.S. Pat. No. 7,862,572, whichclaims the benefit of priority to U.S. Provisional Application60/611,362 filed on Sep. 20, 2004. Application Ser. No. 12/592,174 isalso a Continuation-in-part of Application PCT/US2008/006674 filed onMay 23, 2008 which claims the benefit of priority to U.S. ProvisionalApplication 60/939,887 filed on May 24, 2007. Application Ser. No.12/592,174 is also a Continuation-in-part of application Ser. No.12/175,442 filed on Jul. 17, 2008, now U.S. Pat. No. 7,967,555. Each ofthe aforementioned applications is incorporated by reference herein init entirely.

FIELD

The embodiments disclosed herein relate to a medical device for suturingtissue, and more particularly to a device for the manipulation andcontrol of a suturing needle during minimally invasive suturing, methodsfor making such a device and methods for using such a device forsuturing tissue.

BACKGROUND

Minimally invasive surgery (MIS) has allowed physicians to carry outmany surgical procedures with less pain and disability thanconventional, open surgery. Unlike conventional open surgery, where thesurgical site is readily accessible through a large incision, enablingthe surgeon to easily visualize and manipulate both tissue andinstruments, MIS requires the surgeon to operate remotely by insertingand manipulating instruments through small punctures (“keyhole surgery”)or through natural orifices, including for example the vagina, theesophagus, or the anus.

In MIS, a small puncture is typically made in the body. Medicalinstruments are then inserted through a cannula. A cannula has a smallinside diameter, typically 5-10 millimeters (mm), and sometimes up to 20millimeters (mm) or more. A number of such cannulas may be inserted intothe body for any given operation. Minimally invasive surgicalinstruments are necessarily smaller, and are also generally longer andtherefore are more difficult to manipulate with precision.

Perhaps the most problematic surgical task in MIS is suturing. Suturingrequires coordinated manipulation with both hands of small needles andsutures that are difficult to visualize (particularly when onlyindirect, two-dimensional video imaging is available) as well as theseveral instruments (including needle-drivers and pick-up forceps)ordinarily used to suture by hand. In an environment characterized bylimited space, limited visualization, and limited mobility, manysurgeons find minimally invasive suturing by hand an extremelydifficult, often virtually impossible, surgical task.

In the preferred method of suturing by hand, a grasping forceps (“needledriver”) is held by the surgeon and is used to grip a curved needle nearthe needle's tail. Pronation of the surgeon's wrist drives the needleinto the tissue. When the point of the curved needle emerges from thetissue, the surgeon releases the needle from the grip of the needledriver and grasps the point with another forceps (“pick-ups”). Thesurgeon then pulls the curved needle by the needle point, preferably ina circular path following the arc of the needle's curvature to followthe most atraumatic path through the tissue, until the entire length ofthe needle has exited the tissue. Each time a stitch is placed, thecurved needle is thus driven around in a complete circular arc.Individual (interrupted) stitches are placed by tying off the suturefollowing placement of each stitch. Running (continuous) stitches areplaced by repeatedly driving the curved needle in a complete circulararc repeatedly until the desired length of suture and number of stitcheshas been placed. In order to place additional interrupted or continuousstitches, the surgeon must let go of the point of the needle andre-grasp the needle near the needle's tail.

In the manual suturing technique described above, the direct handling ofthe needle can result in accidental needle pricks through a surgeon ornurse's gloves, posing a potential risk of infection for the surgeon,nurse, staff, and patient, or cause the needle to become contaminatedwith pathogenic bacteria that can cause onset of infection at the siteof the sutures. There is also a risk of the needle penetrating internalorgans or vessels and causing a serious, and often fatal infection.

Various devices for suturing for MIS are described in U.S. Pat. No.5,643,295 entitled “Methods and Apparatus for Suturing Tissue”; U.S.Pat. No. 5,665,096 entitled “Needle Driving Apparatus and Methods ofSuturing Tissue”; U.S. Pat. No. 5,665,109 entitled “Methods andApparatus for Suturing Tissue”; U.S. Pat. No. 5,759,188 entitled“Suturing Instrument with Rotatably Mounted Needle Driver and Catcher”;U.S. Pat. No. 5,860,992 entitled “Endoscopic Suturing Devices andMethods”; U.S. Pat. No. 5,954,733 entitled “Suturing Instrument withRotatably Mounted Needle Driver and Catcher”; U.S. Pat. No. 6,719,763entitled “Endoscopic Suturing Device”; and U.S. Pat. No. 6,755,843entitled “Endoscopic Suturing Device”, all of which are incorporated byreference in their entireties for the teachings therein.

Assignees' U.S. Pat. No. 5,437,681, U.S. Pat. No. 5,540,705 and U.S.Pat. No. 6,923,819 disclose a suturing device with thread managementcomprising a protective cartridge, suturing needle and needle rotationdrive, the disclosures of which are hereby incorporated by reference.The devices described in the above-mentioned patents and patentapplication comprise a mechanism for driving a protected needle however,the needle is rotated about an axis that is parallel to the axis of thedevice. In addition, the orientation and size of the suturing devicemakes it difficult to visualize and cumbersome to use for MIS.

Therefore, there remains a need in the art for a minimally invasivesuturing device that is easily manipulated within the small diameter ofthe cannula; functions in an environment characterized by limited space,limited visualization, and limited mobility; mimics the preferred methodof suturing used by surgeons; permits the surgeon to secure and tieknots quickly and with controlled tension; places continuous stitches;and protects user's from accidental needle sticks during needlehandling, as well as internal organs and vessels, from inadvertentneedle-pricks.

SUMMARY

Devices and methods for minimally invasive suturing of tissue internalto a body are disclosed herein.

According to aspects illustrated herein, there is provided a medicaldevice for closing openings internal to a patient's body, which closelyemulates or replicates the manual suturing actions carried out by asurgeon. The device offers several advantages over conventional methodsused by surgeons for suturing tissue during minimally invasive surgeryin that the device provides a hand-held suturing instrument ofrelatively simple mechanical construction that requires no externalmotive source. The presently disclosed embodiments provide relative easeof operation for the surgeon with only one hand.

According to aspects illustrated herein, a suture head assembly may beremovably attached to an actuator mechanism of the suturing device. Thediameter of the device is small enough to fit into a typical cannula,thus making the device extremely easy to maneuver, as well as suture,during endoscopic or other MIS procedures. Also, the suture headassembly of the device can be laterally articulated to the left ofcenter, to the right of center, up, and down, once inside the cannula,which is ideal for use in the course of endoscopic surgery, includinglaparoscopy, thoracoscopy and arthroscopy, as well as otherless-invasive surgical procedures.

The device of the present disclosed embodiments closely emulates orreplicates the manual suturing actions carried out by a surgeon. Forexample, during manual suturing by hand, the needle is held in forcepsand travels in a circular arc with no obstructions anywhere in theinterior of the arc. The design of the suturing device of the presentdisclosed embodiments allows for a lack of obstruction in the center ofthe arc of the needle during suturing. In other words, there is no hubat the center of the circular arc of the suturing needle. The entirearea within the circular arc of the needle is unobstructed. This allowsfor the user to have better visualization during operation, unlike thepresent mechanical suturing methods, while maintaining control overneedle movement.

In accordance with one embodiment a “locomotive-type” drive mechanism isprovided for advancing the needle about a path of travel. Thisembodiment of a drive enables the small diameter of the device andaffords better visualization during operation because of the lack of ahub. There are many benefits afforded by the design of the suturingdevice of the presently disclosed embodiments, including, but notlimited to, more tissue being able to fit into the device, thus enablinga bigger bite of tissue and a more secure suture; the device can be usedto ligate, that is, place a loop of suture around a blood vessel, duct,or other tubular structure; and the device can be inserted further intosmaller incisions/openings (one side of the aperture can be inserteddeeply, for example).

A benefit provided by the suturing device of the presently disclosedembodiments is that the device enables maneuvering a suturing materialthrough a tissue incision in a manner substantially similar to the way asurgeon would do so by hand. In particular, the suturing device firstpushes a suturing needle from the tail of the needle and drives thepoint of the needle through the tissue. The device then picks up thepoint of the needle that passed through the tissue, and pulls theremainder of the suturing needle and the suture attached to the suturingneedle through the tissue. The suturing needle thus consistently followsthe arc of the needle's own curve, which is the preferred method ofsuturing, in the most atraumatic way of passing a needle through tissue.A benefit provided by the suturing device of the presently disclosedembodiments is the ability of the suturing needle to pull the suturingthread entirely through the tissue segments being closed, following eachstitch. When using the suturing device of the presently disclosedembodiments, no ancillary instruments or tools such as needle holders,pick-up forceps or the like are needed to complete the stitch. A forcepscan be used to tighten the knots.

According to aspects illustrated herein, there is provided a suturingdevice that includes a suturing needle that is protected by a housing,the suturing needle is not exposed to or handled directly by the user,thereby preventing inadvertent needle sticks. The configuration of thesuturing device of the presently disclosed embodiments also protectsagainst inadvertent penetration of internal organs or vessels by theneedle, since the housing acts as a shield between the organs and theneedle.

The suturing device of the presently disclosed embodiments is useful forsuturing tissue internal to a body. An embodiment of the device includesan elongated barrel having a proximal end, a distal end, and alongitudinal axis therebetween; a suture head assembly extending fromthe distal end of the elongated barrel; a suturing needle having apointed end and a blunt end, the suturing needle capable of rotatingabout an axis approximately perpendicular to a longitudinal axis of theelongated barrel, wherein the pointed end of the suturing needle ispositioned within the suture head assembly prior to and after rotationof the suturing needle; and an actuator extending from the proximal endof the elongated barrel to actuate a drive mechanism having a needledriver for engaging and rotating the suturing needle.

According to aspects illustrated herein, there is provided a method forsuturing tissue during minimally invasive surgery that includes: (a)engaging a cartridge to a suture head assembly at a distal end of asuturing device, the cartridge having a protective housing and asuturing needle with a pointed end and a blunt end; (b) introducing thedistal end of the suturing device into a body cavity; (c) positioning anopening in the cartridge to span a plurality of separated tissuesegments or a single tissue segment; (d) activating an actuator coupledto a drive mechanism that engages the suturing needle to causerotational movement of the suturing needle about an axis approximatelyperpendicular to a longitudinal axis of the suturing device and advancethe suturing needle through the plurality of separated tissue segmentsor the single tissue segment; (e) pulling a suturing material attachedto the suturing needle through the plurality of separated tissuesegments or the single tissue segment forming a stitch; and repeatingsteps (c) through (e) to cause a plurality of stitches to be placedthrough the separated tissue segments or the single tissue segment.

According to aspects illustrated herein, there is provided a method forsuturing tissue during minimally invasive surgery that includes: (a)engaging a suturing needle with a pointed end and a blunt end to asuture head assembly at a distal end of a suturing device, the suturehead assembly includes a curved track, whereby the suturing needlefollows a curved path along the track during rotation of the suturingneedle, and a latch that provides a protective housing for the suturingneedle; (b) introducing the distal end of the suturing device into abody cavity; (c) positioning an opening in the needle holder assembly tospan a plurality of separated tissue segments or a single tissuesegment; (d) activating an actuator coupled to a drive mechanism thatengages the suturing needle to cause rotational movement of the suturingneedle about an axis approximately perpendicular to a longitudinal axisof the suturing device and advance the suturing needle through theplurality of separated tissue segments or the single tissue segment; (e)pulling a suturing material attached to the suturing needle through theplurality of separated tissue segments or a single tissue segmentforming a stitch; and repeating steps (c) through (e) to cause aplurality of stitches to be placed through the separated tissue segmentsor a single tissue segment.

According to aspects illustrated herein, there is provided a method forsuturing tissue during minimally invasive surgery that includesinserting a distal end of a suturing device having a suturing needlewith a pointed end into a body; positioning the suturing needle to spana plurality of separated tissue segments; activating an actuator a firsttime causing the pointed end of the suturing needle to extend beyond aprotective housing of a cartridge to engage the plurality of separatedtissue segments; and activating the actuator a second time to cause thesuturing needle to complete a revolution and pull a suture extendingfrom the suturing needle through the plurality of separated tissuesegments to form a stitch.

In addition to the advantages discussed above, the suturing device ofthe presently disclosed embodiments is relatively simple and costefficient to manufacture. Therefore, the suturing device should findwidespread suturing applications that include single stitches orcontinuous stitches, e.g. spiral, mattress, purse string, etc., that arerequired to close tissue incisions, attach grafts, or the like.

These and other advantages of the presently disclosed embodiments areillustrated through the embodiments described hereinafter. The presentlydisclosed embodiments accordingly comprise the features of construction,combination of elements and arrangement of parts that will beexemplified in the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1 is a perspective view of a suturing device of the presentlydisclosed embodiments.

FIGS. 2A and 2B are views of the suture head assembly of the suturingdevice of FIG. 1. FIG. 2A is a perspective assembly view of the suturehead. FIG. 2B is a cutaway perspective view of the suture head.

FIGS. 3A and 3B are segmented assembly views of the suture head assemblyof FIG. 2.

FIGS. 4A and 4B are cutaway segmental views of the suture head assemblyshowing interaction points of a suturing needle with a portion of thedrive mechanism. FIG. 4A shows the position of the suturing needle anddrive mechanism in a “home” position prior to use or after a completefull cycle. FIG. 4B shows the position of the suturing needle and drivemechanism after one full actuation of the handle, where the suturingneedle is in a “rotation” position.

FIGS. 5A and 5B are expanded views of the working end of the suture headassembly with a suturing needle in the home position. FIG. 5A shows therelationship between the pawl and anti-rotate spring when the suturingneedle is in the home position. FIG. 5B shows a close-up view of theanti-rotate spring.

FIGS. 6A and 6B are expanded views of the working end of the suture headassembly during use of the device. FIG. 6A shows the position of thesuturing needle and the pawl immediately after the user squeezes thehandle. The user then releases the handle and the pawl returns to thestart position (FIG. 6B) while the suturing needle remains in therotation position.

FIGS. 7A and 7B are expanded views of the pawl in contact with theC-brace while driving the suturing needle. FIG. 7A shows a close-up viewof the pawl spring loaded with a spring. FIG. 7B shows a close-up viewof the pawl, showing the heel and tip.

FIGS. 8 and 9 are side elevational views of a much larger scale of theinternal portions of the drive mechanism located within the handle andelongated barrel. FIG. 8 shows the drive mechanism when the handle is inan open position and FIG. 9 shows the drive mechanism when the handle isin a closed position.

FIGS. 10-13 are top and bottom views of the suture head assembly,including cables that provide the connection between the drive mechanismlocated in the suture head assembly and the elongated barrel when thehandle is in the open and closed positions. FIG. 10 shows a top viewwhen the handle is in the open position. FIG. 11 shows a bottom viewwhen the handle is in the open position. FIG. 12 shows a top view whenthe handle is in the closed position. FIG. 13 shows a bottom view whenthe handle is in the closed position.

FIG. 14 is a close-up view of the cartridge holder with a tab that locksinto a mating groove on the cartridge holder assembly.

FIG. 15 is a view depicting the suturing needle positioned in the trackof the cartridge.

FIG. 16 is a view showing the relation between the cartridge holderassembly, cartridge, latch and C-brace.

FIGS. 17A, 17B and 17C show the suture head assembly. FIG. 17A shows aside view of the suture head assembly. FIG. 17B is a close-up side viewshowing the relationship between the lever and latch during attachmentand ejection of the needle and cartridge from the cartridge holderassembly. FIG. 17C shows a top view of the suture head assembly.

FIG. 18 is an expanded view of a curved suturing needle with notchesdepicted on the surface of the needle.

FIGS. 19A and 19B depict two exemplary embodiments of the curvedsuturing needle.

FIGS. 20-23 show different views of the suture head assembly attached tothe elongated barrel via a rotation rod. The primary fixation point ofthe suture head assembly to the elongated barrel is depicted as being atthe axis of lateral rotation. FIG. 20 shows a side view of the suturehead assembly. FIG. 21 shows a bottom view of the suture head assembly.FIG. 22 shows a bottom view of the suture head assembly articulated tothe left. FIG. 23 shows a bottom view of the suture head assemblyarticulated to the right.

FIGS. 24 and 25 are perspective views of a suturing device. FIG. 24shows a perspective view of the suturing device with the handles in theopen position. FIG. 25 shows a perspective view of the suturing devicewith the handles in the closed position.

FIG. 26 is a segmented assembly view of the suture head assembly ofFIGS. 24 and 25.

FIGS. 27A and 27B are cutaway segmental views of the suture headassembly of FIGS. 24 and 25 showing interaction points of a suturingneedle with a portion of the drive mechanism. FIG. 27A shows theposition of the suturing needle and drive mechanism in a “home” positionprior to use or after a complete full cycle. FIG. 27B shows another viewof the suturing needle and drive mechanism.

FIG. 28 is a close-up view of the needle holder assembly for the suturehead assembly of FIGS. 24 and 25.

FIG. 29 is a close-up view of the distal end of the suture head assemblyof FIGS. 24 and 25.

FIGS. 30 and 31 show the suture head assembly of FIGS. 24 and 25. FIG.30 shows the suture head assembly with the latch in the open position.FIG. 31 shows the suture head assembly with the latch in the closed orlocked position.

FIG. 32 is a view of a curved suturing needle with notches on the faceof the suturing needle to be used with the suturing device of FIGS. 24and 25.

FIG. 33 shows a view of the pawl in contact with the suturing needle forthe suturing device of FIGS. 24 and 25.

FIGS. 34 and 35 show a close-up view of the suture head assembly ofFIGS. 24 and 25 and the associated pulleys that move the drivemechanism. FIG. 34 shows a top view of the suture head assembly. FIG. 35shows a side view of the suture head assembly.

FIGS. 36 and 37 are top views of the suture head assembly and cablesthat connect the drive mechanism located in the suture head assembly andthe elongated barrel when the handle is in the open position for thesuture device of FIGS. 24 and 25. FIG. 36 shows a top view of the frontpulley and cable when the handle is in the open position. FIG. 37 showsa top view of the return pulley and cable when the handle is in the openposition.

FIG. 38 shows a side elevational view of the suturing device of FIGS. 24and 25 showing parts of the drive mechanism.

FIG. 39A shows a top perspective view of a second embodiment of thesuture head assembly made in accordance with the teachings of theinvention, in which a resilient elongated member moves proximally anddistally to actuate movement of the suturing needle about a circularpath. FIG. 39B depicts the suturing head of FIG. 39A incorporated into asuturing device having a flexible steerable proximal segment.

FIG. 40 shows a sectional view of the drive track of the secondembodiment of the suture head assembly, depicting the course of thedrive tendon, the drive pawl, and the anti-rotate spring in relation tothe suturing needle.

FIG. 41 is a close-up view of the distal end of the drive tendon withattached pawl.

FIG. 42A is an isolated view of the tendon and pawl engaging a notch inthe suturing needle.

FIG. 42B is an isolated view of an exemplary suturing needle that may beused with the second suturing head embodiment, showing a leading notchand a trailing notch on the side of the needle, and an anti-rotate notchon the outer circumference of the needle.

FIG. 43 is a sectional view of the inside structure of the drive trackcomponent of the second embodiment of the suture head assembly, withoutthe tendon, pawl, anti-rotate spring and needle present to highlight theengagement and disengagement tracks, including a flat spring in theproximal chamber used to press the pawl against the drive notch of theneedle.

FIG. 44 is a perspective view of a portion of the inside structure ofthe needle track component of the second embodiment of the suture headassembly, showing one of the pawl body guides, and the aperture throughwhich the anti-rotation spring engages the outer circumference of theneedle.

FIG. 45 is a top perspective view of the second embodiment of the suturehead assembly, showing the placement of the thrust collar over thelateral side of the needle track, enclosing the needle within it.

FIG. 46A is a sectional view through the upper portion of the secondembodiment of the suture head assembly, revealing the cross-section ofthe pawl as it engages the trailing notch of the needle, and showing thedistal ends of both pawl body guides, separating the engagement trackfrom the disengagement track. The relationship of the thrust collar tothe needle and needle track is also apparent.

FIG. 46B is a view of the thrust collar in isolation.

FIG. 47 is a sectional view of the second embodiment of the suture headassembly showing the pawl body positioned against the flat spring, whichurges the pawl tip against the side of the needle. In this view, theneedle is partially spanning the aperture of the suture head assembly,and the anti-rotate spring is visible as it contacts the outercircumference of the needle.

FIG. 48 is an isolated view of the anti-rotate spring.

FIG. 49 is an isolated view of the flat spring, which presses againstthe pawl body to urge the pawl tip against the side of the needle.

FIG. 50A is a sectional view of the second embodiment of the suture headassembly in which the pawl is at the proximal end of the engagementdrive track, immediately proximal to the trailing notch of the needle.

FIG. 50B is a view through section B-B of FIG. 50A showing the pawl tippressed against the side of the needle above the notch by a compressedflat spring.

FIG. 50C is a top view through section C-C of FIG. 50A showing how theflat spring is deflected, pressing the pawl against the side of theneedle.

FIG. 51A is a sectional view of the second embodiment of the suture headassembly in which the pawl is within the trailing notch of the needle atthe proximal end of the engagement drive track.

FIG. 51B is a view through section B-B of FIG. 51A showing how the flatspring is relaxed against the pawl when the pawl tip is within the notchof the needle.

FIG. 51C is a top view through section C-C of FIG. 51A showing the flatspring in a non-deflected state with the pawl tip advanced within thenotch of the needle, now in position to drive the needle forward.

FIG. 52 is a sectional side view of the second embodiment of the suturehead assembly, showing the needle in the ‘home’ position, theanti-rotate spring engaging the needle, and the pawl within the trailingnotch, in position to drive the needle through a suturing cycle.

FIG. 53 is a sectional side view of the second embodiment of the suturehead assembly, showing the needle at the end of the push stroke of thefirst suturing cycle, the pawl having pushed the needle through theaperture, and ready to disengage from the trailing notch.

FIG. 54 is a sectional side view of the second embodiment of the suturehead assembly, showing the pawl being released from the trailing notchinto the distal end of the disengagement track.

FIG. 55 is a sectional side view of the second embodiment of the suturehead assembly, showing the pawl being pulled by the tendon to theproximal end of the track in the pull stroke of the first suturingcycle.

FIG. 56 is a sectional side view of the second embodiment of the suturehead assembly, showing the pawl approaching the proximal chamber wherethe proximal ends of the engagement and disengagement tracks merge. Thedistal end of the tendon has been deflected away from the leading notchof the needle.

FIG. 57 is a sectional side view of the second embodiment of the suturehead assembly, showing the pawl being released into the leading notch ofthe needle by spring force from the distal tendon that had beendeflected as shown in FIG. 56.

FIG. 58 is a sectional side view of the second embodiment of the suturehead assembly, showing the push stroke of the second suturing cycle, inwhich the pointed end of the needle is being advanced to the ‘home’position by the pawl.

FIG. 59 is a sectional side view of the second embodiment of the suturehead assembly, showing the push stroke of the second suturing cyclehaving been completed, the pawl being urged into the distal end of thedisengagement track by the spring force of the distal tendon, and thetrailing notch in proper alignment with the proximal chamber.

FIG. 60 is a sectional side view of the second embodiment of the suturehead assembly, showing the pull stroke of the second suturing cycle,bringing the pawl back to the proximal end of the disengagement track tobe positioned to re-initiate the suturing cycle. Backward rotation ofthe needle is prevented in this stroke by the anti-rotate springengaging the anti-rotate notch of the needle.

FIGS. 61-71B show a further embodiment of a device made in accordancewith the invention.

FIGS. 72-85 show still a further embodiment of a device made inaccordance with the invention.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

The suturing device of the presently disclosed embodiments is showngenerally at 50 in FIG. 1. Referring to FIG. 1, the suturing device 50can be used to produce a continuous or interrupted stitch or suture soas to enable closure of openings internal to a patient's body. Thesuturing device 50 can be utilized to suture any type of anatomicaltissue in any type of anatomical cavity; and, accordingly, while thedevice 50 is described hereinafter for use with a cannula in endoscopicprocedures, such as laparoscopy, the device 50 can be used in opensurgery and with catheters and other small and large diameter tubular orhollow, cylindrical members providing access to small cavities, such asveins and arteries, as well as large cavities, such as the abdomen.

In an embodiment suturing device 50 includes an actuator mechanism showngenerally at 52 which comprises an elongated barrel 54 and a handle 60that extends from the undersides at a proximal end of the elongatedbarrel 54. A suture head assembly 56 is attached to the distal end ofthe elongated barrel 54. In an embodiment, the suture head assembly 56is removably attached to the distal end of the elongated barrel 54. Thelength of the suture head assembly 56 can range from about 20 mm toabout 100 mm. In an embodiment, the length of the suture head assembly56 is about 50 mm. The length of the elongated barrel 54 can range fromabout 50 mm to about 400 mm. Those skilled in the art will recognizethat the elongated barrel 54 can be made shorter or longer depending onthe intended use of the device 50. In an embodiment, the elongatedbarrel 54 is about 300 mm. In an embodiment, the elongated barrel 54 isabout 350 mm. An articulation lever 66, just distal to the top of thehandle 60 is pushed or pulled to cause the suture head assembly 56 torotate. Moving the articulation lever 66 clockwise, moves the suturehead assembly 56 to the right and moving the articulation lever 66counterclockwise, moves the suture head assembly 56 to the left. Thearticulation lever 66 can also be moved to articulate the suture headassembly 56 up and down. The suture head assembly 56 is locked in placewith a locking lever 64 located on an underside of the device 50, belowthe articulation lever 66. The suture head assembly 56 may bearticulated, and the elongated barrel 54 may be any length appropriatefor the intended clinical application of the device 50. The diameter ofthe device 50 can range from about 3 mm to about 20 mm. In anembodiment, the diameter of the device 50 is about 12 mm. In anembodiment, the diameter of the device 50 is about 3 mm. A flush port 62is located on the side of the elongated barrel 54 in order to provide aport of entry for cleaning fluids or suction such that the device 50 canbe cleaned prior to or after use.

The handle 60 is a grip that is squeezed in order to actuate thesuturing device 50. The suturing device 50 is actuated by the actuatormechanism 52 coupled to a drive mechanism 70. The actuator mechanism 52of the suturing device 50 may comprise a triggering mechanism that isknown in the art, such as for example, the triggering mechanismsdisclosed in U.S. Pat. Nos. 6,053,908 and 5,344,061, both of which arehereby incorporated by reference. Alternatively, the actuator mechanismcan be either a manually operable button or switch, or a mechanicallyoperable by an automated electrical or a fuel driven device, such as forexample, an electrical, electromagnetic or pneumatic motor powered byelectrical, electromagnetic, compressed air, compressed gas, hydraulic,vacuum or hydrocarbon fuels. Those skilled in the art will recognizethat any actuator mechanism of any type known in the art can be withinthe spirit and scope of the presently disclosed embodiments.

The suturing needle (e.g., 120, 220) used with the suturing device 50has an engagement or gripping surface at one or more locations along itslength. By way of this surface, an engagement mechanism in the suturehead assembly 56 can grip the needle to advance it through the targettissue. This gripping surface can take on a number of different forms,including, for example, one or more serrations or teeth raised above ordepressed below the generally toroidal surface of the suturing needle,and properly oriented to allow the suturing needle to advance smoothlythrough tissue. In this case, the engagement mechanism in the suturehead assembly 56 can include one or more number of interfitting teeth.The gripping or engagement surface of the suturing needle can also takethe form of hatch marks engraved on the surface of the suturing needle,which either may be raised above or depressed slightly below the surfaceof the suturing needle. In this embodiment, the engagement mechanism inthe suture head assembly 56 can comprise a rubberized contact surface,or a collapsible mesh that can surround the body of the needle at thegripping surface to apply a trapping force against the needle.

In a preferred embodiment, the gripping surface may include one or morenotches that penetrate the surface of a suturing needle that isgenerally toroidal in shape, with the notches located on the outercircumference, inner circumference, or on one or both sides of thesuturing needle. A corresponding engagement mechanism in the suture headassembly 56 can comprise a pawl, which can take many forms, but which ata minimum must effectively contact the leading or forward wall of anotch on the suturing needle, either to drive the needle in a forwarddirection, or to prevent the needle from moving in a reverse direction.The following description uses a particular embodiment of the grippingsurface for illustrative purposes, and is not intended to limit thescope of the invention illustrated herein.

FIG. 2A is a perspective view of the suture head assembly 56 with acartridge holder assembly 90 located at the distal end to which acartridge 88 can be attached. In accordance with one embodiment, thesuture head assembly 56 may be fabricated as a single piece. FIG. 2B isa perspective assembly view of the suture head assembly of the presentlydisclosed embodiments showing part of the drive mechanism 70, shown as agear train/pulley system including pulleys 72, 74, 76 and 78. Locatedwithin the elongated barrel 54 are mechanical parts including driveshafts, belts, rods, cables, or hydraulic tubes which run from theelongated barrel 54 through the spherical portion 58 and then engageswith the drive mechanism 70 in the suture head assembly 56. Connected atthe proximal end of the suture head assembly 56 there is depicted aspherical portion 58 that contains part of the drive mechanism 70including two idler pulleys 80 and cables 84 and 86. The sphericalportion 58 resides within the distal portion of the elongated barrel 54and rotates in a substantially frictionless fashion. In one embodiment,the drive mechanism 70 includes a gear train/pulley system(“locomotive-type” drive mechanism) and cables and rods that extend fromthe distal end of the suture head assembly 56 to the proximal end of theelongated barrel 54.

The suture head assembly 56 is that portion of the device 50 withinwhich the mechanism for driving the curved needle 120 in a complete360-degree circular arc, as well as the cartridge holder assembly 90 forattaching and releasing the cartridge 88 are situated. The suturingdevice 50 is unique in the fact that the orientation of the suture headassembly 56 is such that when the cartridge 88 is attached to the suturehead assembly 56 the needle 120 is driven in a curved path about an axisapproximately perpendicular to the longitudinal axis of the device 50.In this way, the needle 120 may be optimally visualized as the needle120 is driven in a circular arc. Also, as shown in FIG. 2B, the needle120 and cartridge 88 are in a plane parallel to the drive mechanism 70and fit into the same space in the suture head assembly 56.

The improved visibility offered by the shape and configuration of thesuture head assembly 56 enables precise device placement over theincision or other target tissue of interest, and uniform advancement ofthe suturing device 50 after every stitch to provide a uniform andsymmetric suture, thereby minimizing the risk of tearing tissue andbleeding due to a stitch being positioned too close to the edge of theincised tissue. In one embodiment, the entire device 50 or parts of thedevice 50, such as the suture head assembly 56, the elongated barrel 54,the handle 60, and the needle 120 and cartridge 88, may be composed of asterilizable medical grade plastic material, in which case, the entiredevice 50 or parts of the device 50 may discarded and disposed after asingle use. In another embodiment, the device 50 may be composed of asterilizable medical grade metallic material such as stainless steel toenable reuse subsequent to sterilization following a prior use. In stillanother embodiment, the device 50 is composed of a sterilizable medicalgrade metallic material such as titanium to enable reuse subsequent tosterilization following a prior use. The use of titanium is ideal forcertain procedures including Magnetic Resonance Imaging (MRI) andComputed Tomography (CT) because they are X-Ray radiolucent and do notinterfere with MRI and CT scans.

FIGS. 3A and 3B provide detailed segmental views of the suture headassembly 56 showing the cartridge holder assembly 90, the disposableneedle cartridge 88, a curved suturing needle 120, and parts of thedrive mechanism 70 including a plurality of pulleys, 72, 74, 76, 78 and80 involved in driving the needle driver 98 through a semicircular path.In one embodiment, the needle driver is a pawl 98. As depicted, ashoulder screw 108 is used to keep a latch 110 locked in place over thedisposable cartridge 88 and the suturing needle 120. Pulleys 72, 74, 76and 78 are engaged with an actuator arm 102, which is attached to thepawl 98. The pawl 98 interfits with two notches 132 (as depicted in FIG.15) located on the needle 120 at 180 degrees apart from each other whichdrives the curved needle 120 in a completely circular arc. The suturehead assembly 56 is preferably configured so that the pawl 98 (or otherneedle driver), does not intrude into or obstruct the area within thecurve of the needle 120. The entire area within the circular arc of theneedle 120 is unobstructed; there is no hub at the center of thecircular arc so that the device 50 can encompass the maximum volume oftissue within the circular arc of the curved needle 120. In this way,the needle 120 may be rotated through a relatively large arc, allowingthe needle 120 to obtain a sufficient “bite” into the tissue.Preferably, the needle 120 will have a radius of curvature of about 3 mmto about 40 mm. In an embodiment, the device 50 sutures within the limitof the diameter of the suture head assembly 56, which is advantageous tosuturing through small cannulas during minimally invasive surgery. In anembodiment, the diameter of the curved needle 120 does not exceed thediameter of the suture head assembly 56.

FIGS. 4A and 4B show detailed views of the drive mechanism 70 located inthe suture head assembly 56 with respect to driving the needle 120during use of the device 50 (the cartridge housing 88 has been removedto show the drive mechanism 70 in detail). The drive mechanism 70includes a plurality of pulleys, 72, 74, 76 and 78, and the associatedaxel pins 82, involved in driving the pawl 98 through a semicircularpath. The actuator arm 102 engages pulleys 72 and 76 and are pinned 75to pulleys 72 and 76. As pulleys 76 and 78 rotate with the motion of thecables 86 and 84, respectively, that reside in the elongated barrel 54(not shown), pulley 74 acts as an idler pulley, transferring the motionto the most distal pulley 72. Pulley 72 and pulley 76 rotate throughidentical arcs. The actuator arm 102 provides a connection to the pawl98. The pawl 98 is located in the distal end of the actuator arm 102.The pawl 98 is attached to the actuator arm 102 by an integral shaft andcollar 100 that fits loosely into the actuator arm 102 allowing smoothmovement. As the handle 60 is closed and opened, the pawl 98 movesthrough the same arc as pulleys 72 and 76. The pawl 98 at the distal endof the actuator arm 102 is capable of engaging the notches 132 locatedalong the radially inner edge of the needle 120. The actuator arm 102 isactivated by the user upon squeezing of the handle 60, and is capable ofsweeping back and forth in an arc spanning about 190 degrees or more.FIG. 4A shows a detailed view of the drive mechanism 70 and the suturingneedle 120 either prior to using the device 50 or after one completefull cycle of the device 50. FIG. 4B shows a detailed view of the drivemechanism 70 and the suturing needle 120 after one squeeze of the handle60. As shown, the drive mechanism 70 has moved in a circular arc greaterthan about 180 degrees, (about 190 degrees), while the suturing needle120 has moved in a circular arc of about 190 degrees to drive throughthe tissue or vessel to be sutured.

The outer surface of the actuator arm 102 is shaped to accommodate aC-brace (shown as 106 in FIG. 7) that causes the pawl 98 to engage theneedle 120 and thereby remain in contact. The advancing movement of theneedle 120 during operation causes the notches 132 along the radiallyinner edge of the needle 120 to align with the pawl 98 in the actuatorarm 102, thereby causing the pawl 98 to engage the notches 132 due to apositive pressure exerted by the C-brace (not shown), and to “lock” intothe notches 132. The rotary advancing movement of the needle 120 istherefore controlled to occur sequentially through about 190 degreeseach time the needle is actuated.

FIG. 5A shows a close-up view of the distal end of the suture headassembly 56 with the cartridge 88 and the needle 120 in view as well asthe relationship between the pawl 98 and the actuator arm 102 withrespect to the needle 120. The needle 120 is enclosed within thecartridge 88, so the sharp pointed end 124 is not exposed. This needleposition, as loaded, is referred to as the “home” position (FIG. 5A). Inthe home position, the needle 120 is fully contained within thecartridge housing 88 to eliminate needle-pricks during handling of thecartridge 88 or the loaded device. Squeezing the device handle 60 fully,two times, operates the device 50 through one full cycle. As shown inFIG. 6A, the first full actuation of the handle 60 drives the needle 120through an about 190 degree arc. The pointed end of the needle 124 exitsthe protective enclosure of the cartridge 88, drives through the tissueto be sutured, and re-enters the protection of the cartridge 88 of thedevice 50. This position, after the first squeeze of the handle 60, isreferred to as the “rotation” position. As shown in FIG. 6B, the handle60 is then released, and the needle 120 remains in the rotation positionwhile the pawl 98 and the actuator arm 120 return to their startposition. The handle 60 is then squeezed again driving the needle 120through an about 190 degree arc and returning the needle 120 to the homeposition.

FIG. 5A shows the needle 120 in the home position, the pawl 98 isengaged in the notch 132 near the suture end of needle 126. Ananti-rotate spring 136 is engaged in the notch 134 on the outer surfaceof the needle 120, not allowing the needle 120 to move backwards in thecartridge 88 of the device 50. A close-up view of the anti-rotate spring136 is shown in FIG. 5B. In an embodiment, the needle 120 comprises atleast one anti-rotate notch 134 and is engaged with at least oneanti-rotate spring 136. As the pawl 98 drives the needle 120 through afirst semicircular arc, the anti-rotate spring 136 slips out of thenotch 134 and slides over the outer surface of the needle 120. As thepawl 98 reaches the end of a first drive stroke, the anti-rotate spring136 snaps in behind the rear corner of the needle 120, near the suturingmaterial or thread 146 (see FIG. 6A). As the pawl 98 returns to thestart position, the anti-rotate spring 136 holds the needle 120 inplace, preventing the needle 120 from moving with the pawl 98 backtoward the start position. The pawl 98 returns to the start position andengages the notch 132 in the needle 120 near the pointed end 124 (seeFIG. 6B). When the handle 60 is squeezed a second time, the needle 120is driven back to the home position.

The width of the aperture 118 in the cartridge 88 is comparable to andcorresponds with the width of the gap in the needle 120 so that when theneedle 120 is in the home position (as shown in FIG. 5A) the needle 120does not project materially into the aperture 118. Such an alignmentcauses the needle 120 to reside entirely within the cartridge 88,thereby preventing inadvertent contact of the sharp pointed end 124 withthe user's fingers during handling of the disposable needle cartridge 88for placement on the cartridge holder assembly 90 or disposal after use,and while operating the suturing device 50. Such protection of theneedle 120 in the suturing device 50 prevents accidental “needle-pricks”from occurring, thereby substantially reducing the risk of infectioncaused by pathogenic bacteria or viruses that may contaminate the needle120 during or after use prior to disposal. The needle 120 may be rotatedin a curved track 92 of the cartridge 88 about the longitudinal axis ofthe suturing device 50 to advance the pointed needle end 124 so that theneedle 120 first spans the aperture 118 and then returns to the homeposition. The suturing material or thread 146 is attached to the needle120, and therefore follows the path of the needle 120. The suturingmaterial or thread 146 may then be cut and secured by an appropriatemethod, such as for example, by tying, or additional stitches may beplaced along the entire wound or incision by repeating theaforementioned process. Every stitch, whether a single, interruptedstitch, or one of a series of continuous, running stitches may be placedin like manner. The suturing device 50, therefore, may be used to inserteither a single stitch, or to insert a suture comprising a plurality ofcontinuous stitches as a replacement method for a more tedious andtime-consuming manual suturing process. The terminal end of the suturingmaterial or thread 146 may contain a knot or button to prevent thesuturing material or thread 146 from pulling through the sutured tissueduring placement of the first stitch. In an embodiment, the cartridge 88comprises the suturing needle 120 attached to the terminal end suturingmaterial or thread 146, and an appropriate length of suturing materialor thread 146 are all packaged in a sterilizable medical packagingmaterial.

FIG. 7A shows a close-up view of the pawl 98 which rides in a trackformed by the C-brace 106 and the suture head assembly 56. The pawl 98is spring loaded with a spring 104. The spring 104 is engaged to the tipof the pawl 98 b as shown in FIG. 7A. The spring 104 engages the pawltip 98 b into the notch 132 in the needle 120 during the driving strokeof the device 50 when the handle 60 is closed. The spring 104 alsoallows the tip of the pawl 98 b to rotate out of notch 132 of the needle120 during the return of the pawl 98 to the start position when thehandle 60 is opened. The heel of the pawl 98 a stays in contact with theC-brace 106 during the driving stroke of the device 50, preventing thepawl 98 from over-rotating and locking the needle 120. FIG. 7B shows aclose-up view of the pawl 98 showing the pawl heel 98 a and the pawl tip98 b.

Referring now to FIGS. 8 and 9 in conjunction with FIG. 1, the userintroduces the distal end portion of suturing device 50 into a bodycavity, via a cannula assembly (not shown), and then laterallyarticulates the suture head assembly 56 using the articulation lever 66located just distal to the top of the handle 60. The suture headassembly 56 is then positioned relative to the tissue/vessel to besutured, and the user locks the suture head assembly 56 in place usingthe locking lever 64. The user then, through manipulation of suturingdevice 50, positions a plurality of separated tissue segments into theopening defined at the distal end portion of the suture head assembly 56and within the aperture of the cartridge 118. The user, using only onehand, may manipulate the device 50 while actuating the handle 60 toclose an incision with a continuous suture whose stitches may beindividually tensioned precisely and uniformly along the length of thesuture similar to suturing done by hand in the conventional way. Theuser may employ a single suture which would extend the entire length ofthe incision or multiple sutures.

The device 50 starts with the needle 120 in the home position and thehandle 60 fully open (see FIG. 8). In an embodiment, the handle 60 ismade up of a grip which rests in the user's palm and is squeezed inorder to actuate the device 50. To drive the needle 120 through thetissue to be sutured, the user squeezes the handle 60 moving the needle120 from the home position to the rotation position. The handle 60contains linkages 144 to both the upper drive rod 142 and the lowerdrive rod 140. Squeezing the handle 60 (see FIG. 9) causes the two driverods 140 and 142 to move in opposite directions. The upper drive rod142, moves forward while the lower drive rod 140 moves backward. Thedrive rods are connected to the suture head assembly 56 with cables 84and 86 and idler pulleys 80. The upper rod 142 is connected to pulley 78with cable 84. The lower rod 140 is connected to pulley 76 with cable86.

FIGS. 10 and 11 in conjunction with FIG. 8, show the connections andpositions of cables 84 and 86 and the drive pulleys 72, 74, 76 and 78when the handle 60 is in the open position. FIGS. 12 and 13 inconjunction with FIG. 9, show the connections and positions of cables 84and 86 and the drive pulleys 72, 74, 76 and 78 when the handle 60 is inthe closed position. The force to move needle 120 from the home positionto the rotation position comes from the lower rod 140 pulling backwardon the drive cable 86. The lower rod 140 extends nearly the full lengthof the elongated barrel 54, connecting to drive cable 86, at theproximal end of the elongated barrel 54. As shown in FIG. 11, cable 86exits the elongated barrel 54 and enters the suture head assembly 56,passing over an idler pulley 80 located in the spherical portion 58,then wrapping clockwise (as viewed from the bottom) around pulley 76 andis secured to pulley 76 located in the suture head assembly 56. Thepulling action of cable 86 causes pulley 76 to rotate through an arc ofapproximately 190 degrees. As lower rod 140 pulls backward, the upperrod 142 moves forward. The upper rod 142 also extends nearly the fulllength of the elongated barrel 54, connecting to drive cable 84, at theproximal end of the elongated barrel 54. As shown in FIG. 10, cable 84also exits the elongated barrel 54 and enters suture head assembly 56,passing over a second idler pulley 80 located in the spherical portion58, then wrapping (clockwise as viewed from the top) around pulley 78and is secured to pulley 78 located in the suture head assembly 56.Pulley 78 is directly linked to pulley 76 through the actuator arm 102,and cables 84 and 86 are wrapped in opposing directions, so that ascable 86 unwinds from pulley 76, cable 84 winds onto pulley 78.

The needle 120 is held in a path of rotation by a combination of threecomponents. The cartridge 88, the C-brace 106 and the cartridge holderassembly 90 interact to constrain the needle 120 to the path of rotation(see FIG. 5). The cartridge 88 is a semicircular shaped component thatis held into the device 50 by a plurality of extensions 94 located oneach end of the cartridge 88 (see FIGS. 14 and 15). In an embodiment,the plurality of extensions 94 takes the form of tabs. In an embodiment,the cartridge 88 is made from a sterilizable medical grade metallicmaterial such as stainless steel. The cartridge 88 provides some of thesupport structure for keeping the needle 120 in a rotational path andtherefore should be constructed from a material with structuralintegrity. Those skilled in the art will recognize that anyhigh-strength medical grade material may be used to fabricate thecartridge 88, such as a high-strength plastic. In an embodiment, theplurality of extensions are tabs extending from the cartridge housing88. The plurality of extensions 94 lock into mating grooves 96 locatedalong on the distal edge of the cartridge holder assembly 90 that arelocated diametrically opposite to one another, and are capable ofengaging the plurality of extensions 94 correspondingly located in theneedle cartridge housing 88 as shown in FIG. 16.

The proximal end of cartridge 88 is held in place by a cartridge holderassembly 90, as shown in FIG. 17A. The cartridge holder assembly 90 alsoincludes a latch 110, a lever 112, associated pins 114 and 116, ashoulder screw 108, an anti-rotate spring 136 and at least one groove 96that can engage with the plurality of extensions 94 located on thecartridge 88. It is the interaction of all of the elements of thecartridge holder assembly 90 that hold and lock the cartridge 88 inplace. The latch 110 slides back to release the cartridge 88 and forwardto lock the cartridge 88 in place. The latch 110 also has a built intoejector feature, as shown in FIG. 17B. A lever 112 is located distal andbelow the needle 120 and the cartridge 88. The lever 112 pivots on a pin114. A second pin 116 located above the pivot pin 114, engages with aslot in the latch 110. To release the needle 120 and the cartridge 88,the latch 110 is pulled back and the lever 112 is rotated up and back,causing pin 116 to move back with the latch 110 and to rotate about pin114 thus pushing the needle 120 and the cartridge 88 from the cartridgeholder assembly 90. The needle 120 and the cartridge 88 are then removedfrom the device 50 by a slight proximal motion to disengage theplurality of extensions 94 from their mating grooves 96 in the cartridgeholder assembly 90. FIG. 17C shows the needle 120 as it is driventhrough a first semicircular arc (the handle 60 has partially completeda first full squeeze). As the pawl 98 drives the needle 120 through afirst semicircular arc, the anti-rotate spring 136 slips out of thenotch 134 and slides over the outer surface of the needle 120.

Loading of the needle 120 and the cartridge 88 is accomplished byengaging the plurality of extensions 94 into both grooves 96 on thecartridge holder assembly 90 and then pressing the proximal ends downagainst the sloped distal surface of the latch 110. The latch 110 isspring loaded at the proximal end, thus can slide back as the needle 120and the cartridge 88 are pressed into place and then snap closed to thelocked position, retaining the needle 120 and the cartridge 88. Thelever 112 is down and out of the way of the operation of the needle 120and the cartridge 88.

FIG. 18 shows a close-up view of the needle 120. The two notches 132 arelocated about 180 degrees apart on the inner surface and assist indriving the needle 120. The pawl 98 engages the notches 132 when drivingthe needle 120 through the circular motion. A third notch 134 is locatedon the outer surface of the needle 120. The notch 134 assists inpreventing rotation of the needle 120 and provides an anti-rotationfeature. In an embodiment (see FIGS. 19A and 19B), the needle 120 isformed as a circular split ring with a gap 122, a sharp, pointed end124, and a blunt end 126. The needle 120 further comprises an opening130 to accommodate the leading end of the suturing material or thread146. In one embodiment, the opening 130 is the form of an eye thoughwhich the leading end of the suturing material or thread 146 may bepassed through for attachment to the needle 120. In the illustratedneedle 120 (FIG. 19A), the opening 130 is located adjacent to the bluntend 126. The opening 130 however, can be positioned anywhere along thearc or the needle 120 between the apex 128 and the blunt end 126. Inanother embodiment (FIG. 19B), the needle 120 comprises an opening 130in the form of a cylindrical bore aligned axially with respect to theneedle 120, located at the blunt end 126 (FIG. 19B). The leading end ofthe suturing material or thread 146 is inserted into the opening 130 andrestrained by mechanically crimping. To enable the needle 120 topenetrate tissue to a required depth, the arc length of the needle 120is preferably about 240 degrees to about 300 degrees. The needle 120comprises two symmetric notches 132 along the radially inner edge(“inner notches”) that are positioned proximally to the sharp, pointedend 124 and the blunt end 126 of the needle 120. The notches 132 arelocated directly opposite to each other, each having a perpendicular(about 90 degree) segment and an angular segment that makes an angle ofabout 60 degrees with the perpendicular segment. The inner notches 132are engaged by the needle driver 98 of the drive mechanism 70 and enablethe needle 120 to undergo a rotary movement upon actuation of the drivemechanism 70, thereby causing the needle 120 to penetrate into andadvance through tissue. A similar triangular notch 134 is located on theradially outer edge (“outer notch”) of the needle 120 proximally to theinner notch 132 closer to the sharp, pointed end 124. The outer notch134 engages with the anti-rotate spring 136 located on the cartridgeholder assembly 90, whereby rotation of the needle 120 in a directionopposite to the advancing direction or “needle backing-up” is prevented.The positive engagement of the needle outer notch 134 during operationof the suturing device precludes needle 120 from straying out ofsequence during the suturing process.

The suture head assembly 56 of the device 50 can be laterallyarticulated to the left of center and also to the right of center. Inone embodiment, the suture head assembly 56 can be laterally articulatedthrough an arc of about 22.5 degrees to the left of center and also tothe right of center, for a total of about 45 degrees or more. Inaddition, the suture head assembly can be articulated up and down. Inone embodiment, the suture head assembly 56 can be articulated up anddown. The ability of the suture head assembly 56 to be articulated tothe left and right of center, as well as up and down, permits the userto position the suture head assembly 56 for many different types ofsuturing applications. The articulation lever 66, just distal of the topof the handle 60, is pushed or pulled to cause the suture head assembly56 to rotate. Viewed from above, moving the articulation lever 66clockwise moves suture head assembly 56 to the right and moving thearticulation lever 66 counterclockwise moves suture head assembly 56 tothe left. The suture head assembly 56 is locked in place with thelocking lever 64 located on the bottom of the device 50, below thearticulation lever 66. Movement is accomplished using the solidarticulation rod 68 to link the articulation lever 66 to the suture headassembly 56. The articulation rod 68 is pinned to the articulation lever66 and to one side of the most proximal section of the suture headassembly 56 so that the articulation rod 68 pushes or pulls the suturehead assembly 56 through a full range of motion (see FIGS. 20-23).

FIGS. 20-23 show the articulation rod 68 in the elongated barrel 54 andthe connection to the suture head assembly 56. The suture head assembly56 is shown moving from left articulation, to straight to rightarticulation (some components are not shown to allow clear viewing ofthe linkage). FIG. 20 shows a side view of the suture head assembly 56.FIG. 21 shows a bottom view of the suture head assembly 56 with noarticulation. FIG. 22 shows a bottom view of the suture head assembly 56articulated to the left. FIG. 23 shows a bottom view of the suture headassembly 56 articulated to the right. FIGS. 20-23 show a number ofitems. The articulation rod 68 runs down the center of the elongatedbarrel 54 and is attached to one side of the spherical portion 58. Thefunction of the articulation rod 68 is to push and pull the suture headassembly 56 through an articulation. The two idler pulleys 80, whichdrive cables 84 and 86 are located in the spherical portion 58. Lookingat FIG. 20, the two idler pulleys 80 seem to be one on top of the other.Instead however, they are located in plane with either pulley 76 andlower rod 140 or pulley 78 and upper rod 142.

In accordance with one embodiment, the entire suturing device 50 can bedesigned as a single unit which may be either reusable or disposed aftera single use. If desired, the entire suturing device 50 can be designedfrom a number of units which, each unit may be either reusable ordisposed after a single use.

The suturing device 50 is preferably configured to provide a “pistollike” grip for the user that includes an elongated barrel 54 and ahandle 60 that extends from the proximal end of the elongated barrel 54.The elongated barrel 54 has either a linear or non-linear configuration,including but not limited to, straight, curved and angledconfigurations. A suture head assembly 56 is removably attached to thedistal end of the elongated barrel 54. The suture head assembly 56contains a portion of the drive mechanism 70 of the device 50. Theworking end of the suture head assembly 56 has a cartridge holderassembly 90 to which a disposable cartridge 88 that is capable ofaccommodating a suturing needle 120 may reside.

The disposable cartridge 88 preferably has a generally cylindricalhousing with an opening or aperture 118 in the sidewall of the housingat the distal or working end thereof. An arcuate suturing needle 120having a sharp, pointed end 124 is slidably mounted in a circular track92 of the cartridge 88. A blunt end of the needle 126 is connected to asuturing material or thread 146. The radius of the arc defining thearcuate suturing needle 120 is approximately equal to the circumferenceto the cartridge housing 88 at the aperture 118 therein. The needle 120normally resides in a “home” position in the track 92 such that the gapin the arcuate suturing needle 122 is in alignment with the aperture 118in the cartridge 88. The sharp, pointed end of the needle 124 issituated on one side and entirely within the confines of the housingaperture 118; the pointed end of the needle 124 is, therefore, shieldedby the cartridge housing 88. The blunt end of the suturing needle 126that is attached to the suturing material or thread 146 is located atthe opposite side of the aperture 118. The sharp, pointed end of theneedle 124 is, therefore, wholly contained within the cartridge 88 anddoes not protrude beyond the housing of the cartridge 88. Thus, thesharp pointed end of the needle 124 is not exposed to the user.

In accordance with the presently disclosed embodiments, the needle 120may be releasably engaged by a needle driver 98 that is rotatablymounted within the suture head assembly 56 so that the needle 120 can berotated from the home position by about 360 degrees about the centralvertical axis of the cartridge 88. Such a rotary action of the needle120 causes the sharp point 124 to advance across the cartridge housing88 so as to span the aperture 118. Thus, when the device 50 ispositioned such that the incised tissue segments to be sutured aresituated at the housing aperture 118, the needle 120 penetrates thetissue segments and spans the incision between them. A continued rotarymovement of the needle 120 causes the needle 120 to return to the homeposition, and thereby causes the suturing material or thread 146attached to the needle 120 to be pulled into and through the tissue inan inward direction on one side of the tissue incision, and upwards andout through the tissue on the opposite side of the incision. Thus, thesuture material or thread 146 follows the curved path of the needle 120to bind the tissues together with a stitch of material or thread 146across the incision in a manner similar to manual suturing, wherein theneedle 120 is “pushed” from the blunt end 126 and then “pulled” from thepointed end 124 by the pawl 98. Preferably, an anchoring mechanism isprovided at the trailing terminal end of the suturing material or thread146 to prevent the material 146 from being pulled completely through andout of the tissue segments. For example, the anchoring mechanism can bea pre-tied or a welded loop, a knot wherein the suture material orthread 146 is simply tied, or a double-stranded, looped suture is thatattached to the suturing needle 120. The rotary movement of the needle120 within the needle cartridge 88 is accomplished by a pawl 98 that maybe operated by the user by holding the suturing device 50 with one handin a pistol-like grip around the handle 60, and using at least onefinger of that hand to activate.

The suturing device 50 of the presently disclosed embodiments can beused for a laparoscopic procedure, including but not limited tolaparoscopic colostomy, colectomy, adrenalectomy, splenectomy, repair ofparaesophageal hernia, inguinal hernia repair, ventral hernia repair,Nissen fundoplication, liver lobectomy, gastrectomy, small bowelresection, treatment of small bowel obstruction, distal pancreatectomy,nephrectomy and gastric bypass. Those skilled in the art will recognizethat the presently disclosed embodiments can be used in otherlaparoscopic procedures.

In using the device 50 of the presently disclosed embodiments, theabdomen is insufflated with gas to create a working space for the user.Any gas known to those skilled in the art including, but not limited to,nitrogen or carbon dioxide, can be used. Access portals are establishedusing trocars in locations to suit the particular surgical procedure. Avariety of surgical instruments may then be inserted into the bodythrough these access ports/cannulas. The user then introduces the distalend portion of suturing device 50 into a cannula, and then laterallyarticulates the suture head assembly 56 using the articulation lever 66located just distal to the top of the handle 60. The suture headassembly 56 is then positioned relative to the tissue/vessel to besutured together, and the user locks the suture head assembly 56 inplace using the locking lever 64. The user then, through manipulation ofsuturing device 50, positions a plurality of separated tissue segmentsinto the opening defined at the distal end portion of the suture headassembly 56 and within the aperture 118 of the cartridge 88. The user,using only one hand, may manipulate the device 50 while actuating thehandle 60 to close an incision with a continuous suture whose stitchesmay be individually tensioned precisely and uniformly along the lengthof the suture similar to suturing done by hand in the conventional way.The user may employ a single suture which would extend the entire lengthof the incision or multiple sutures. Thus, by placement of the device 50with the needle cartridge aperture 118 spanning the incised tissuesegments and actuating the handle 60, the suturing device 50 enables theuser to lay down a running stitch or interrupted stitch to close thetissue incision in a time efficient manner. Those skilled in the artwill recognize that any conventional procedure for conductinglaparoscopic surgery can be used with the device 50.

The needle cartridge 88 is disposably mounted on a cartridge holderassembly 90 at the distal end of the suture head assembly 56. Theminimalized structural design of the suture head assembly 56 enables theuser to have a clear, unobstructed view of the suturing needle 120during advancement through the tissue segments during the course of asuturing operation, thereby enabling precise placement of the suturingdevice 50 to provide uniform sutures and precluding the risk of tearingtissue by placement too close to the edge of the incision. The suturingdevice 50 is then advanced a short distance along the incision and theaforementioned operation is repeated to produce another stitchcomprising the suturing material or thread 146.

The user may continue to manipulate the suturing device 50, alternatelyadvancing and actuating rotation of the needle 120 about an axis that isgenerally parallel to the direction of advancement to create acontinuous suture which may extend through the entire length of theincision or a series of interrupted stitches. After each individualstitch is laid down, the stitch is tightened by exerting a pull on thesuturing material or thread 146 so that the resultant suture istensioned uniformly along the length of the incised tissue segments.Therefore, a tight closure of the segments is accomplished and bleedingand tearing of tissue are minimized. Once the appropriate amount ofsuture material or thread 146 has been placed, the user can use a needlegrasper to tighten and knot the formed stitches.

The presently disclosed embodiments provide a method for suturing tissueduring minimally invasive surgery including engaging a cartridge 88 to asuture head assembly 56 at a distal end of a suturing device 50, thecartridge 88 having a protective housing and a suturing needle 120 witha pointed end 124 and a blunt end 126; introducing the distal end of thesuturing device 50 into a body cavity; positioning an opening 118 in thecartridge 88 to span a plurality of separated tissue segments;activating an actuator 52 coupled to a drive mechanism 70 that engagesthe suturing needle 120 to cause rotational movement of the suturingneedle 120 about an axis approximately perpendicular to a longitudinalaxis of the suturing device 50 and advance the suturing needle 120through the plurality of separated tissue segments; and pulling asuturing material 146 attached to the suturing needle 120 through theplurality of separated tissue segments forming a stitch.

The presently disclosed embodiments provide a method for suturing tissueduring minimally invasive surgery including (a) engaging a cartridge 88to a suture head assembly 56 at a distal end of a suturing device 50,the cartridge 88 having a protective housing and a suturing needle 120with a pointed end 124 and a blunt end 126; (b) introducing the distalend of the suturing device 50 into a body cavity; (c) positioning anopening 118 in the cartridge 88 to span a plurality of separated tissuesegments; (d) activating an actuator 52 coupled to a drive mechanism 70that engages the suturing needle 120 to cause rotational movement of thesuturing needle 120 about an axis approximately perpendicular to alongitudinal axis of the suturing device 50 and advance the suturingneedle 120 through the plurality of separated tissue segments; (e)pulling a suturing material 146 attached to the suturing needle 120through the plurality of separated tissue segments forming a stitch andrepeating steps (c) through (e) to cause a plurality of stitches to beplaced through the separated tissue segments.

The presently disclosed embodiments provide a method for suturing tissueduring minimally invasive surgery including inserting a distal end of asuturing device 50 having a suturing needle 120 with a pointed end 124into a body; positioning the suturing needle 120 to span a plurality ofseparated tissue segments; activating an actuator 52 a first timecausing the pointed end 124 of the suturing needle 120 to extend beyonda protective housing of a cartridge 88 to engage the plurality ofseparated tissue segments; activating the actuator 52 a second time tocause the suturing needle 120 to complete a revolution and pull a suture146 extending from the suturing needle 120 through the plurality ofseparated tissue segments to form a stitch.

The suturing device 50 may be configured in different ways with respectto length and angle of the suture head assembly 56. The size of theneedle 120, the needle cartridge 88, the cartridge aperture 118 and theaperture position may also be varied for use in open surgery to performprocedures such as closing of the fascia, skin closure, soft tissueattachment, anastomosis, fixation of mesh, grafts and other artificialmaterials.

FIGS. 24 and 25 show an alternative embodiment of a suturing deviceshown generally at 150. Referring to FIGS. 24 and 25, the suturingdevice 150 can be used to produce a continuous or interrupted stitch orsuture so as to enable closure of openings internal to a patient's body.The suturing device 150 can be utilized to suture any type of anatomicaltissue in any type of anatomical cavity; and, accordingly, while thedevice 150 is described hereinafter for use with a cannula in endoscopicprocedures, such as laparoscopy, the device 150 can be used in opensurgery and with catheters and other small and large diameter tubular orhollow, cylindrical members providing access to small cavities, such asveins and arteries, as well as large cavities, such as the abdomen.

In an embodiment, the suturing device 150 includes an actuator mechanismshown generally at 152 which comprises an elongated barrel 154 and ahandle 160 that extends from the undersides at a proximal end of theelongated barrel 154. Located within the elongated barrel 154 aremechanical parts including cables which run from the elongated barrel154 through a spherical portion 158 and then engages with the drivemechanism in a suture head assembly 156. The spherical portion 158resides within the distal portion of the elongated barrel 154 androtates with low friction. In an embodiment, a drive mechanism 170includes a pulley system and cables that extend from the distal end ofthe suture head assembly 156 to the proximal end of the elongated barrel154.

The suture head assembly 156 houses the mechanism for driving a curvedneedle 220 in a complete 360 degree circular arc. The orientation of thesuture head assembly 156 is such that when the needle 220 is attached tothe suture head assembly 156 the needle 220 is driven in a curved pathabout an axis approximately perpendicular to the longitudinal axis ofthe device 150. In this way, the needle 220 may be optimally visualizedas the needle 220 is driven in a circular arc. Also, as shown in FIGS.24 and 25, the needle 220 is in a plane parallel to the drive mechanismand fits into the same space in the suture head assembly 156.

The improved visibility offered by the shape and configuration of thesuture head assembly 156 enables precise device placement over theincision, and uniform advancement of the suturing device 150 after everystitch to provide a uniform and symmetric suture, thereby minimizing therisk of tearing tissue and bleeding due to a stitch being positioned tooclose to the edge of the incised tissue. In one embodiment, the entiredevice 150 or parts of the device 150, such as the suture head assembly156, the elongated barrel 154, the handle 160, and the needle 220, arecomposed of a sterilizable medical grade plastic material, in whichcase, the entire device 150 or parts of the device 150 may discarded anddisposed after a single use. In an embodiment, the device 150 iscomposed of a sterilizable medical grade metallic material such asstainless steel to enable reuse subsequent to sterilization following aprior use. In another embodiment, the device 150 is composed of asterilizable medical grade metallic material such as titanium to enablereuse subsequent to sterilization following a prior use. The use oftitanium is beneficial for certain procedures including MagneticResonance Imaging (MRI) and Computed Tomography (CT) because they areX-Ray radiolucent and do not interfere with MRI and CT scans.

FIG. 24 shows the handle 160 in an open position. FIG. 25 shows thehandle 160 in the closed position. The suture head assembly 156 isattached to the distal end of the elongated barrel 154. In oneembodiment, the suture head assembly 156 is removably attached to thedistal end of the elongated barrel 154. The length of the suture headassembly 156 can range from about 10 mm to about 100 mm. In a particularembodiment, the length of the suture head assembly 156 is about 40 mm.The length of the elongated barrel 154 can range from about 50 mm toabout 400 mm. Those skilled in the art will recognize that the elongatedbarrel 154 can be made shorter or longer depending on the intended useof the device 150. In one embodiment, the elongated barrel 154 is about300 mm in length. In another embodiment, the elongated barrel 154 isabout 350 mm in length. An articulation lever 166, just distal to thetop of the handle 160 is pushed or pulled to cause the suture headassembly 156 to rotate. Moving the articulation lever 166 clockwisemoves the suture head assembly 156 to the right and moving thearticulation lever 166 counterclockwise moves the suture head assembly156 to the left. The articulation lever 166 can also be moved toarticulate the suture head assembly 156 up and down, as desired. Thesuture head assembly 156 is locked in place with a locking lever 164located on an underside of the device 150, below the articulation lever166. The suture head assembly 156 may be articulated, and the elongatedbarrel 154 may be any length appropriate for the intended clinicalapplication of the device 150. The diameter of the device 150 can rangefrom about 3 mm to about 20 mm. In one embodiment, the diameter of thedevice 150 is about 12 mm. In another embodiment, the diameter of thedevice 150 is about 3 mm.

The handle 160 may be a grip that is squeezed in order to actuate thesuturing device 150. The suturing device 150 is actuated by the actuatormechanism 152 coupled to a drive mechanism 170. The actuator mechanism152 of the suturing device 150 may comprise a triggering mechanism thatis known in the art, such as for example, the triggering mechanismsdisclosed in U.S. Pat. No. 6,053,908 and U.S. Pat. No. 5,344,061, bothof which are hereby incorporated by reference. Alternatively, theactuator mechanism 152 can be either a manually operable button orswitch, or mechanically operable by an automated electrical or a fueldriven device, such as for example, an electrical, electromagnetic orpneumatic motor powered by electrical, electromagnetic, compressed air,compressed gas, hydraulic, vacuum or hydrocarbon fuels. Those skilled inthe art will recognize that any actuator mechanism of any type known inthe art can be within the spirit and scope of the presently disclosedembodiments.

FIG. 26 provides an assembly view of the suture head assembly 156. Thesuture head assembly 156 is fabricated from multiple pieces including aholder assembly 190, a needle holder assembly 188, a latch 210, andparts of the drive mechanism 170 including a plurality of pulleys, 172,174 and 176 and two idler pulleys 180 involved in driving a needledriver 198 through a semicircular path. Pulleys 172 and 174 may includea set of four pulleys, or two sets of pulleys, labeled 178. In oneembodiment, the needle driver is a pawl 198. A shoulder screw 208 and aplurality of needle assembly extensions 194 may be used to keep thelatch 210 locked in place over the needle holder assembly 188 and thesuturing needle 220. The needle holder assembly 188 includes a curvedtrack 192 where the needle 220 rides. Pulleys 172, 174 and 176 areengaged with an actuator arm 202, which is attached to the pawl 198. Thepawl 198 interfits with two notches 232 located on the face of theneedle 220 at about 180 degrees apart which drives the curved needle 220in a circular arc. The suture head assembly 156 is configured so thatthe pawl 198 or other needle driver known in the art, does not intrudeinto or obstruct the area within the curve of the needle 220. The areawithin the circular arc of the needle 220 is unobstructed; there is nota hub at the center of the circular arc so that the device 150 canencompass the maximum volume of tissue within the circular arc of thecurved needle 220. In this way, the needle 220 may be rotated through arelatively large arc, allowing the needle 220 to obtain a sufficient“bite” into the tissue. Preferably, the needle 220 will have a radius ofcurvature of about 3 mm to about 40 mm. In one embodiment, the device150 sutures within the limit of the diameter of the suture head assembly156, which is advantageous to suturing through small cannulas duringminimally invasive surgery. In one embodiment, the diameter of thecurved needle 220 does not exceed the diameter of the suture headassembly 156.

FIGS. 27A and 27B show detailed views of the drive mechanism 170 locatedin the suture head assembly 156 with respect to driving the needle 220during use of the device 150 (the needle holder assembly 188 and theholder assembly 190 have been removed to show the drive mechanism 170 indetail). The drive mechanism 170 includes the actuator arm 202 thatengages pulleys 172, 174, and 176 and the pawl 198 that drives theneedle 220 through a curved path. The pawl 198 is located in the distalend of the actuator arm 202 and is capable of engaging the notches 232located along the face of the needle 220. A flat spring 200 keeps thepawl 198 engaged into the notches 232 of the needle 220. When the needle220 is pushed around, the pawl 198 will be pushed back up against theflat spring 200 and allow the needle 220 to cycle. As the handle 160 isclosed and opened, the pawl 198 moves through the same arc as thepulleys. The actuator arm 202 is activated by the user upon squeezing ofthe handle 160, and is capable of sweeping back and forth in an arcspanning about 190 degrees or more.

FIG. 28 shows a close-up view of the needle holder assembly 188 showingthe curved track 192 where the needle 220 resides as well as the needleholder assembly extensions 194 that help keep the latch 210 in place.The suturing needle 220 follows a curved path along the track 192 duringrotation of the suturing needle 220. The curved track 192 for the needle220 may be machined into the needle assembly 188 and provides a captivecurved track 192 so that the needle 220 can be driven around withprecision. The curved track 192 includes an inside slot and a largerslot surrounding the inside slot. The larger outside slot providesclearance for the pawl 198, so that the pawl 198 can maneuver aroundwithout hitting anything, and the smaller inside slot provides clearancefor a pawl tip 199, which goes through the smaller inside slot and theninto the needle 220 so that the pawl tip 199 can drive the needle 220.

FIG. 29 shows a close-up view of the suture head assembly 156 with theneedle holder assembly 188, the holder assembly 190, the latch 210 andthe needle 220 in view as well as the relationship between the pawl 198and the actuator arm 202 with respect to the needle 220. The needle 220is enclosed within the needle holder assembly 188, so the sharp pointedend 224 of the needle 220 is not exposed. This needle 220 position, asloaded, is referred to as the “home” position. In the home position, theneedle 220 is fully contained within the needle holder assembly 188 toeliminate needle-pricks during handling of the suture head assembly 156.The needle assembly extensions 194 form a “tongue-in-groove” connectionwith the latch 210, which keeps the forces from the needle 220 fromopening the thin members of the latch 210. The needle assemblyextensions 194 cause an entrapment at a distal end of the suturingdevice, thus locking the latch 210 in place. Squeezing the device handle160 fully operates the device 150 through one full cycle. The first fullactuation of the handle 160 drives the needle 220 through about a190-degree arc. The pointed end 224 of the needle 220 exits theprotective enclosure of the needle holder assembly 188, drives throughthe tissue to be sutured, and re-enters the protection of the needleholder assembly 188 of the device 150. This position, after the firstsqueeze of the handle 160, is referred to as the “rotation” position.The handle 160 is then released, and the needle 220 remains in therotation position while the pawl 198 and the actuator arm 220 return totheir start position. The handle 160 is then squeezed again driving theneedle 220 through about a 190-degree arc returning the needle 220 tothe home position. A flat pawl spring 200 keeps the pawl 198 engagedinto the pawl notches 232 on the needle 220. When the needle 220 ispushed around the pawl 198 will be pushed back up against the flat pawlspring 200 and allow the needle 220 to cycle.

FIGS. 30 and 31 show top views of the suture head assembly 156. Needleholder assembly 188 forms a connection with the latch 210. The latch 210forms a top cover over the suturing needle 220 which is in the curvedtrack 192 of the needle holder assembly 188. FIG. 30 shows the latch 210in the open position, which is for needle 220 removal and insertion intothe needle holder assembly 188. To insert and/or remove the needle 220 auser may turn the needle 220 180 degrees in its curved track 192 fromthe as-drawn position. A user may grab the needle 220 by hand or with asurgical tool to either install the needle 220 or remove the needle 220.By grabbing and lifting the needle 220 out, the needle 220 is removed.By grabbing the needle 220 the needle can be inserted when the latch 210in the open position. FIG. 31 shows the latch 210 in the lockedposition, also known as the forward position.

FIG. 32 shows the suturing needle 220. The two notches 232 are locatedabout 180 degrees apart on the face of the needle 220 and assist indriving the needle 220. The pawl 198 engages the notches 232 whendriving the needle 220 through the circular motion. A third notch 234 islocated on the outer surface of the needle 220. The notch 234 providesan anti-rotation feature by preventing rotation of the needle 220. Theneedle 220 is formed as a circular split ring with a gap 222, a sharp,pointed end 224, and a blunt end 226. The needle 220 further comprisesan opening 230 to accommodate the leading end of the suturing materialor thread 246. In an embodiment, the opening 230 is the form of an eyethough which the leading end of the suturing material or thread 246 maybe passed through for attachment to the needle 220. In the illustratedneedle 220, the needle 220 comprises an opening 230 in the form of acylindrical bore aligned axially with respect to the needle 220, locatedat the blunt end 226. The opening 230, can be positioned anywhere alongthe arc or the needle 220 between the apex 228 and the blunt end 226.The leading end of the suturing material or thread 246 is inserted intothe opening 230 and restrained by mechanically crimping or otherconnection methods known in the art. To enable the needle 220 topenetrate tissue to a required depth, the arc length of the needle 220is preferably about 240 degrees to about 300 degrees. The needle 220comprises two symmetric notches 232 along the face (“drive notches”).The notches 232 are located directly opposite to each other. A similarnotch 234 is located on the radially outer edge (“outer notch”) of theneedle 220 proximally to the inner notch 232 closer to the sharp,pointed end 224. The outer notch 234 engages with an anti-rotate spring,whereby rotation of the needle 220 in a direction opposite to theadvancing direction or “needle backing-up” is prevented. The positiveengagement of the needle outer notch 234 during operation of thesuturing device precludes the needle 220 from straying out of sequenceduring the suturing process.

FIG. 33 shows a close-up view of the pawl tip 199 engaging the drivenotches 232 of the needle 220. The drive notches 232 are engaged by thepawl tip 199 of the drive mechanism 170 and enable the needle 220 toundergo a rotary movement upon actuation of the drive mechanism 170,thereby causing the needle 220 to penetrate into and advance throughtissue.

FIGS. 34 and 35 show parts of the drive mechanism 170 including returnpulleys 172 and 174. Pulleys 172 and 174 are connected to each otherusing wires 175. As can be seen in FIG. 27A and FIG. 27B, pulleys 172and 174 are made up of four pulleys 178 that are connected together bylaser welding or other methods known in the art. The four pulleys 178produce an over-rotation, of about 190 degrees. The over-rotation leadsto the wire 175 design where there is a wire 175 on each set of pulleys178. As shown in FIG. 34 and FIG. 35, there are two wires 175 with fourpulleys 178, resulting in the four pulleys 178 being in synch with oneanother, even under load. The four pulleys 178 are rotationally in sync,i.e., one pulley 178 will follow the other pulley 178, because the wires175 are configured to be pulling against one another. The wire 175 maybe attached to the pulleys 178 via a hole that the wires 175 aresoldered into. FIG. 35 shows a side view of the suture head assembly 156which shows the two wires 175 connecting the four pulleys 178 togetherfor synchronized rotation.

FIGS. 36 and 37 in conjunction with FIG. 38, show the connections andpositions of cables 184 and 186 to the drive pulley 176 and to thereturn pulleys 172 and 174, respectively, and to the when the handle 160is in the open position. The cables 184 and 186 may be made fromstainless steel. Connected at the proximal end of the suture headassembly 156 there is the spherical portion 158 that contains part ofthe drive mechanism 170 including two idler pulleys 180 and cables 184and 186. FIG. 36 shows a top view of the suture head assembly 156 withthe cable 184 running through two idler pulleys 180 and wrapped arounddrive pulley 176. FIG. 37 shows a top view of the suture head assembly156 with the cable 186 running through two idler pulleys 180 and wrappedaround return pulley 174. The cable 186 runs from return pulley 174through the elongated barrel 154 and to the very proximal end of thehandle 160. The force to move the needle 220 from the home position(shown in FIGS. 36 and 37) to a rotation position comes from a returnspring 240 that is connected to the cable 184, resulting in a pre-load(shown in FIG. 38). When the trigger of the handle 160 is squeezedclosed, the handle 160 moves to the closed position and the drive pulley176 turns counterclockwise, driving the needle 220. At the same time,the cable 186 drives the return pulley 174 counterclockwise and cyclesthe actuator arm 202 to drive the needle 220 forward through the tissue.The needle 220 is driven through a circular motion, through a cycle, andthe cable 184 is compressing the return spring 240 on the other end.When the handle 160 closes more, the actuator arm 202 drives the needle.When the trigger of the handle 160 is released, the front pulley 178,which is now fully charged with the return spring 240, will return theneedle 220 to the home position. The return spring 240 pulls cable 184,returning the pulleys to their starting positions, and returning theactuator arm 202 to a position to engage the second drive notch ofneedle 220. A second compression-release cycle returns the needle 220 tothe home position. Relaxing the trigger of handle 160 takes no power.

FIG. 38 shows a side elevational view of the suturing device 150. Thehandle 160 includes a number of internal parts—a cable connector 182 hasa hole and a shoulder. The shoulder rides against the end of the returnspring 240, and the hole provides an opening for the cable 184. Thereturn spring 240 is compressed and the cable 184 is soldered or lockedto the connector 182, so that the cable 184 provides a preload onto thereturn spring 240. The cable 184 runs from the connector 182 through thereturn spring 240 over pulley 244, through the elongated barrel 154,through the spherical portion 158, between the idler pulleys 180 andfixed to the drive pulley 176. The cable 186 is connected at the veryproximal end of the handle 160 and lies under pulley 245, over pulley242, through the elongated barrel 154, through the spherical portion158, between the idler pulleys 180 and fixed to the return pulley 174.

When the handle 160 is translated from the open position to the closedposition the needle 220 is driven through the tissue. A user has atactile feel as the needle 220 moves. If the needle 220 runs acrosssomething that is impenetrable, the handle 160 will stop moving and theuser could feel this in their hand holding the handle. When the handle160 is in a closed position, the return spring 240 takes on a charge,the return spring 240 has shortened in length. When the handle 160 isreleased, the return spring 240 pulls the cable 184 and brings theneedle 220 back to the home position and also brings the handle 160 backto the open position. The return spring 240 provides a load on the cable184. A loop is formed throughout the suturing device 150 that includesthe cables 184 and 186 and the pulleys 172, 174 and 176 such that cable184 is attached at one end to the return spring 240, at the other end tothe drive pulley 176. The cable 186 is attached to the return pulley 174and then cable 186 attaches to the very proximal end of the handle 160,thus forming a loop. The return spring 240 can be set to a desiredspring-rate so that the return spring 240 performs as desired by theuser. The return spring 240 should have a small amount of preload tomake sure that the handle 160 opens all the way, which provides that thedriving mechanism 170 would return the needle 220 to the home position.

The cables 184 and 186 extend through the elongated barrel 154 andconnect to the drive mechanism 170 in the suture head assembly 156. Thelong length of the cables 184 and 186 provides a small amount of aspring buffer. If the suturing device 150 were to become bound orsomething locked up at the suture head assembly 156 this would nottranslate. If the user continued to pull on the handle 160 to close thehandle 160, the cables 184 and 186 would stretch and should not break.The two idler pulleys 180, which drive the cables 184 and 186 arelocated in the spherical portion 158. As shown in FIG. 34, the two idlerpulleys 180 appear to be one on top of the other, but they are locatedin a plane with either pulleys 174 and 176 or pulley 178 (see FIG. 26).

FIG. 39 shows an alternative embodiment of a suture head assembly 356.The actuator arm 102 (FIGS. 3A, 4A and 4B) of the suture head assembly56 is replaced by a tendon or band filament 302 (FIG. 39). The cables 84and 86, and drive rods 140 and 142 (FIG. 8) can be replaced by anactuator that can move fore and aft with compression and release of thehandle 60 (FIG. 8) or 160 (FIG. 24). The actuator can be a drive rod(not shown), and can be constructed of a tensile material that permitslateral elastic flexibility but minimal longitudinal compressibility,such as steel or other metal alloys with spring-like qualities, shapememory alloys, such as NITINOL® or a flexible hardened polymer orplastic such as high density polyethylene or polypropylene. The driverod can be encased within a passageway inside the elongated barrel 54,the walls of which can include a sufficiently lubricious material tominimize the friction of the fore and aft movement of the drive rod. Forexample, the passageway may be made from or include a coating of afluoropolymer or other lubricious material, such as silicone oil and thelike. The drive rod can be connected on its distal end to the tendon orfilament 302 by any suitable means (including, for example, the use of ascrew, a bolt, adhesive, a weld joint, a hinge joint, or a snap-lockconnection).

The suture head assembly 356 can be attached rigidly to the elongatedbarrel 54. Alternatively, the suture head assembly 356 can be attachedmoveably to the elongated barrel 54 by an articulating joint as shown inFIG. 2A and FIGS. 20-23. For example, the proximal end of the suturehead assembly 356 (FIG. 39) can be modified to form a partiallyspherical portion similar to spherical portion 58 (FIG. 2A), which canpermit superior-inferior motion of the suture head assembly 356 withrespect to the elongated barrel 54. An articulation rod 68 can be usedas shown in FIGS. 20-23 to push and pull the suture head assembly 356through an arc within the limits of the articulation. Those skilled inthe art will recognize there are many possible means of connecting anembodiment exemplified by the suture head assembly 356 to a handle andactuating mechanism to achieve the push-pull motion of the tendon orfilament 302.

As shown in FIG. 39A, in this embodiment the suture head assembly 356 iscomprised of two mating components 356A and 356B. A needle track 332 islocated in the needle track component 356B. A drive track (not shown) islocated in the drive track component 356A next to the needle track 332.In this embodiment, the suturing needle 220 exits the suture headassembly 356 from the distal end of aperture 318, and re-enters thedevice at the proximal end of aperture 318. Therefore, in its ‘home’position, the blunt end 226 of needle 220, and its attached suturematerial 246 are situated more proximally in the suture head assembly356 than the pointed end 224 (not shown).

By way of further example, as depicted in FIG. 39B, device 300 equippedwith a suture head assembly 356 may be provided with a flexible proximalsegment 354 and include a steering mechanism for controlling curvatureof the shaft. The steering mechanism may achieve steering in anysuitable manner, such as steering wires. For example, two, four or anyother suitable number of steering wires 371 may be used to controlmovement of device 300. Steering may be controlled accordingly by way ofa steering control mechanism 372, which may be made in any way known inthe art. Similar to the embodiments of FIGS. 1-38, an actuator 373 isalso provided for activating the suturing head. As will be appreciatedby those of skill in the art, the embodiments of FIGS. 1-38 maysimilarly be modified to include a flexible barrel (54, 154), asdesired.

As embodied herein, the tendon 302 may include an elongated flexiblemember that can slide fore and aft within a track in the suture headassembly 356. It can have any cross-sectional shape, including forexample, round, oval, square, or rectangular. In a preferred embodiment,it is relatively flat, forming a band, which has the advantage oflimiting the flexibility of the tendon 302 to one lateral dimension(e.g., superior-inferior and not side-to-side). It is preferablyconstructed of material that is minimally compressible, allowing for thelongitudinal transmission of a pushing as well as a pulling force. Inone embodiment, the material from which a tendon is constructed hassufficient tensile properties to exert a spring-like force that opposeslateral flexion. Examples of material with such properties can include,for example, shape memory alloys such as NITINOL®, steel or other metalalloys with spring-like qualities, or a flexible hardened polymer orplastic such as high density polyethylene or polypropylene. In otherembodiments, spring-like properties on lateral flexion are not required,where, for example, the lateral movement of the tendon is urged by aspring located with the suture head assembly 356 that exerts a forceagainst the external surface of the tendon.

As shown in FIG. 40, the tendon 302 is situated in a drive track 333within the drive track component 356A of the suture head assembly 356.The drive track 333 is substantially straight until it reaches thedistal portion of the suture head assembly 356, which at this point isshaped to define an aperture 318. At this location the drive track 333in one embodiment divides into an engagement track 334, anddisengagement track 335, which each follow a curved path conforming tothe contour of the suturing needle 220. As shown in FIG. 41, tendon 302flexes to conform to the shape of the engagement and disengagementtracks 334 and 335. FIG. 41 shows a perspective view of the distalflexed end of tendon 302, to which is attached a cylindrical pawl 308.The pawl 308 consists of a pawl body 308A and a pawl tip 308B. Thecylindrical shape of the pawl body 308A and pawl tip 308B reduce thefrictional resistance to movement of the tip of tendon 302 withinengagement and disengagement tracks 334 and 335. Other cross-sectionalshapes of the pawl assembly 308A and 308B are also possible, including,for example, an oval, a square a rectangle, or other more complexshapes. Moreover, the pawl body can also be constructed as a rollerbearing, further reducing frictional resistance to the fore and aftmotion of the tendon 302. FIG. 42A shows how the pawl tip 308B engages atrailing notch 232B or leading notch 232A on needle 220 to allow thetendon 302 to advance the needle 220 within its track 332. FIG. 42Bshows the needle 220 in isolation, in which the drive notches 232A and232B are located on the side of the needle 220, and the anti-rotatenotch 234 is located on the outer circumference of the needle 220. Apointed end 224 pierces the target tissue during forward rotation of theneedle 220, and suture material 246 is attached to the blunt end 226 ofneedle 220.

In one embodiment, notches 232A and 232B have a substantiallyperpendicular leading wall 232A1 and 232B1 against which the pawl tip308B can engage and move the needle forward in its track 332; whereasthe angled trailing walls 232A2 and 232B2 allow the pawl tip 308B toslide smoothly into position in the notches 232 and 233 as it advanceswithin the engagement track 334. The leading walls 232A1 and 232B1 ofnotches 232A and 232B can also be inclined away from the pointed end ofthe needle, the angle of inclination being in the range of about 91degrees to about 160 degrees with respect to the surface of the needle.The trailing walls 232A2 and 23B2 of notches 232A and 232B can also beinclined away from the pointed end of the needle, the angle ofinclination being in the range of about 91 degrees to about 160 degreeswith respect to the surface of the needle.

Alternatively, the trailing wall 232B2 of trailing notch 232B can alsobe made substantially perpendicular to the surface of the needle, with agap between the leading wall 232B1 and the trailing wall 232B2 largeenough to accommodate the pawl tip 308B. This embodiment allows the usereither to advance the needle 220 by pushing the tendon 302 distally, ormove the needle backwards by pulling the tendon 302 proximally when thepawl tip 308B is engaged in the trailing notch 232B. The surgeon canthus ‘back out’ the needle from the tissue being sutured when anobstacle is encountered that prevents complete penetration of the needle220, or when repositioning of the needle in tissue is desired for otherreasons. Under these circumstances, the leading wall 233A1 of leadingnotch 232A is preferably not angled away from the pointed end in orderto avoid a ‘barb-like’ structure that would impede reversal of theneedle path in tissue. In addition, the leading wall 233A1 can have achamfered or rounded corner at the junction with the surface of needle220 to facilitate backing the needle out of tissue. For the samereasons, the anti-rotate notch 234 can have a leading wall that does notangle away from the pointed end 224 of the needle 220, and it can have achamfered or rounded corner at the junction with the surface of theneedle 220. The trailing wall 232B2 of trailing notch 232B can also beconstructed with a chamfered or rounded corner to facilitate forwardmovement of the needle through tissue.

As shown in FIG. 43, in one embodiment, the track 333 divides intoengagement track 334 and disengagement track 335. Engagement track 334is adjacent to and side-by-side with the needle track 332. Disengagementtrack 335 is adjacent to the outside circumference of engagement track334. Pawl body guides 336A (FIG. 43) and 336B (FIG. 44) separateengagement track 334 from disengagement track 335, except for a gapbetween the pawl body guides 336A and 336B running the length of thetracks 334 and 335. (best shown in FIG. 46A) The base of pawl body guide336A is either formed or attached along the inside wall of the drivetrack side 356A of suture head assembly 356. The base of pawl body guide336B is either formed or attached along the inside wall of the needletrack side 356B of suture head assembly 356. The pawl body guides 336Aand 336B terminate short of the ends of the tracks 334 and 335, both attheir proximal and distal ends, at proximal chamber 380 and distalchamber 390. This allows engagement track 334 to be in fullcommunication with disengagement track 335 at both the proximal chamber380 and the distal chamber 390 of the tracks. Tendon 302 moves onlywithin engagement track 334, whereas the distal end 302A of tendon 302and pawl 308 can move in engagement track 334 when driving needle 220,and move in disengagement track 305 when returning to proximal chamber380. At the proximal end 308 of the engagement and disengagement tracks334 and 335 (i.e. at the proximal chamber 380), the spring force causedby tendon 302 being flexed in a downward direction causes the pawl 308to move up into the proximal end of engagement track 334. As the tendonmoves distally in the track 334, it engages the trailing notch 232B orleading notch 232A of needle 220, moving the needle 220 forward in itstrack 332. When the pawl 308 reaches the distal end of the track 334 atthe distal chamber 390, the tendon 302 is flexed in an upward direction,and the spring force of tendon 302 now exerts a downward force on thepawl 308. The pawl 308 drops down into the distal end of disengagementtrack 335. The distal end of tendon 302 comprises a narrowed segment302A, allowing this distal segment to travel within the disengagementtrack 335 as tendon 302 is pulled proximally, because the narrowerdimension of the distal end of tendon 302 clears the pawl body guides336A and 336B. The more proximal portion of tendon 302, at full width,continues to travel in engagement track 334, being held in place by thepawl body guides 336A and 336B.

FIG. 45 shows a top perspective view of the suture head assembly 356.The drive track side 356A is mated to the needle track side 356B. Theneedle track 332 is formed on the outside surface of the needle trackside 356B of the suture head assembly 356. In this embodiment, a secondopening 357, located at the distal end of aperture 318, is where thepointed end 224 of needle 220 exits the device. A first opening 358,located at the proximal end of aperture 318, is where the pointed end224 of needle 220 re-enters the suture head assembly 356 afterpenetrating the target tissue. FIG. 46A shows a cutaway top perspectiveview of suture head assembly 356, in which the roof of track 333, theproximal chamber 380, and the distal chamber 390 have been cut away. Thepawl 308 can be seen in cross-section within the proximal end ofengagement track 334, adjacent to the cross-section of needle 220 attrailing notch 232B. Pawl tip 308B is engaged in trailing notch 232B ofneedle 220. The pawl 308 is held within the track by pawl body guides336 A and 336B. The narrow segment 302A of tendon 302 can pass throughthe gap between pawl body guides 336A and 336B. Thus while the mainportion of tendon 302 remains within engagement track 334, the pawl 308and narrow segment 302A of tendon 302 can travel either in engagementtrack 334 or engagement track 335. A thrust collar 360, shown in FIG.46A (and in isolation in FIG. 46B) snaps over the outside of needle 220into suture head assembly 356 to hold needle 220 within its needle track332. Alternatively, a cartridge 88, as shown in FIG. 2A and FIG. 2B, canbe used, which can then be attached to a cartridge holder assembly 90. Acartridge 88 can provide operating room personnel with the added safetyof avoiding inadvertent puncture from handling an exposed needle 220.

A further enhancement of suture head assembly 356 is shown in FIG. 47.An anti-rotate spring 346 (shown in isolation in FIG. 48), anchoredinside suture head assembly 356 can engage a notch on the outercircumference of needle 220 to prevent backward migration of needle 220in its track 332. As shown in FIG. 44, the anti-rotate spring 346contacts the surface of needle 220 through an aperture 347 lateral tothe disengagement track 335 so as not to interfere with movement of thedistal end of tendon 302 and pawl 308. In a preferred embodiment, theanti-rotate notch 234 is located on the outer circumference of needle220, and sufficiently distally along the needle to cause engagement ofthe anti-rotate spring 346 only when the pointed end of needle 220 iswithin the confines of suture head assembly 356.

An additional feature to coax pawl 308 to engage the notch 232A or 232Bof needle 220 is shown in FIG. 47. A flat spring 348 (shown in isolationin FIG. 49) is situated within proximal chamber 380 of the drive trackside 356A of suture head assembly 356. The flat spring 348 urges thepawl 308 against the side of needle 220 to engage the pawl tip 308B witheither the trailing notch 232B or leading notch 232A. The force exertedby flat spring 348 is substantially weaker than the spring force exertedby the downwardly flexed tendon 302, allowing the distal end of tendon302 and the pawl 308 to move into position at the proximal end ofengagement track 334, compressing flat spring 348 if necessary. Thus itis possible for pawl 308 to engage the notch 232A or 232B of needle 220even if the pawl 308 and notch 232A or 232B are not exactly adjacent toone another. FIG. 50A is a cross-sectional view of suture head assembly356 showing pawl 308 positioned immediately proximal to trailing notch232B of needle 220. FIG. 50B is a view of FIG. 50A through section B-B.Pawl tip 308B is pressed against the side of needle 220 immediatelyproximal to notch 232B by compressed flat spring 348. FIG. 50C is a viewof FIG. 50A through section C-C. Flat spring 348 deflected by pawl 308,maintaining pressure of pawl tip 308B against the side of needle 220.FIG. 51A is a cross-sectional view of suture head assembly 356 showingpawl 308 positioned within trailing notch 232B of needle 220. FIG. 51Bis a view of FIG. 51A through section B-B. At this point, pawl tip 308Bis engaged with notch 232B of needle 220, spring 348 is in a relaxedposition, and pawl 308 is aligned with the side wall of engagement track334, allowing it to proceed distally to drive the needle 220 within itsneedle track 332. FIG. 51C is a view of FIG. 51A through section C-C.Flat spring 348 is now in a relaxed position, and pawl tip 308B issituated within notch 232B of needle 220. Once the pawl 308 movesdistally within engagement track 334, the confines of the track wallitself keep the pawl tip 308B engaged with notches 232B or 232A.

FIGS. 52-59 are sectional views through the length of suture headassembly 356 showing the progression of a complete four stroke movement(two push-pull cycles) that causes needle 220 to undergo a 360 degreerotation within its track 332, penetrating the target tissue in thefirst stroke of the first cycle. In FIG. 52, the pawl 308 is situated atthe proximal end of engagement track 334, and is engaged with notch 232Bof needle 220. Anti-rotate spring 346 is engaged with the anti-rotatenotch 234 on the outer circumference of needle 220, preventing it frommoving in a reverse direction. In FIG. 53, the tendon 302 has beenpushed distally in a first stroke, and has driven pawl 308 to the distalend of engagement track 334. When the ends of pawl guides 336A and 336Bhave been cleared, the distal end of tendon 302 and pawl 308 snap byspring force into the distal end of disengagement track 335. In thisembodiment, movement of needle 220 by pawl 308 in this stroke has causedthe pointed end of needle 220 to exit the second opening 357 of suturehead assembly 356, traverse the aperture 318, penetrated the targettissue, and re-entered the first opening 358 of suture head assembly356. In FIG. 54, the pawl 308 and the distal end of tendon 302 havedropped into the distal end of the disengagement track 335 by springforce of the upwardly deflected tendon 302. The pull stroke in the firstsuturing cycle is shown in FIG. 55. The pawl 308 is being pulled bytendon 302, which is being retracted proximally by the surgeon via thehandle 60 or 160. Backward migration of the needle 220 is prevented bythe engagement of anti-rotate spring 346 against the hub or blunt end226 of needle 220. This helps to keep the leading notch 232A of needle220 aligned with the proximal chamber 380, where the pawl 308 can engageit. In FIG. 56, the pawl 308 has reached the end of the pull stroke atthe proximal end of disengagement track 335. At this point the tendon302 is significantly deflected downward, generating a spring force todrive pawl 308 upward into the proximal end of engagement track 334,after it has cleared the pawl body guide 336A and 336B. In FIG. 57, thepawl 308 has been driven by spring force into engagement with theleading notch 232A of needle 220. The push stroke of the second suturingcycle involves pushing the tendon 302 distally, driving the pawl 308 andpointed end 224 of needle 220 toward the distal end of needle track 332(visually indistinguishable from engagement track 334 in this view).This is shown in FIG. 58, where the pointed end 224 of needle 220 hasadvanced half-way through needle track 332. In FIG. 59, the push strokeof the second suturing cycle has been completed, with the pawl havingdropped into the distal end of disengagement track 335 by spring forcefrom the upward deflection of tendon 302. The needle 220 has returned toits home position. Backward movement of the needle 220 is prevented byanti-rotate spring 346 engagement with the anti-rotate notch 234 ofneedle 220. The trailing notch 232B of needle 220 is in position to beengaged by pawl 308 at the proximal end of engagement track 334. Asshown in FIG. 60, the pull stroke of the second suturing cycle is aretraction of tendon 302 proximally, pulling the pawl 308 proximallywithin disengagement track 335 and bringing it into position in theproximal chamber 380 to re-engage the trailing notch 232B of needle 220.Backward migration of needle 220 is prevented by anti-rotation spring346 engaging the anti-rotation notch 234 of needle 220. The suturingcycle is ready to resume if desired at this point.

Those skilled in the art will recognize that the movement of the distalend 302B of tendon 302 and pawl 308 into and out of notches 232A and232B can be effected by springs situated within the suture head assembly356 at the beginning of disengagement track 335 and at the end ofengagement track 334. Externally applied spring force, or even theplacement of ramps in the engagement and disengagement tracks can causethe pawl 308 to be re-directed into the proximal end of engagement track334, and into the distal end of disengagement track 335.

It will also be apparent to those skilled in the art that the directionof travel of needle 220 can be reversed by having the home position forthe trailing notch situated in the distal end of needle track 332. Inthis case, the pawl and tendon are situated at the distal end ofengagement track 334 at the start of the first stroke of the firstsuturing cycle. The first (pull) stroke of the cycle would cause thepointed end of needle 220 to exit the first opening 358, pass throughthe target tissue, and re-enter the suture head assembly at the secondopening 357. Structured in this way, the disengagement track 335 wouldbe equipped with a spring or ramp to press the pawl 308 into the notch232A or 232B at the distal end of the track, and with a spring or rampto disengage the pawl 308 from the notch 232A or 232B at the proximalend of the track. Alternatively, the disengagement track 335 can beconstructed so that it lies within the inner circumference of theengagement track 334 and needle track 332. Under this circumstance, thespring-like property of tendon 302 will naturally drive the pawl 308into notch 232A or 232B at the distal end, and out of notch 232A and232B at the proximal end.

In an embodiment, the entire suturing device 150 can be designed as asingle unit which may be either reusable or disposed after a single use.In one embodiment, the entire suturing device 150 can be designed from anumber of separable parts where each unit may be either reusable ordisposed after a single use.

The suturing device 150 is configured to provide a “pistol like” gripfor the user that includes an elongated barrel 154 and a handle 160 thatextends from the proximal end of the elongated barrel 154. The elongatedbarrel 154 has either a linear or non-linear configuration, includingbut not limited to, straight, curved and angled configurations. A suturehead assembly 156 is removably attached to the distal end of theelongated barrel 154. The suture head assembly 156 contains a portion ofthe drive mechanism 170 of the device 150. The working end of the suturehead assembly 156 has a needle holder assembly 188 to which a suturingneedle 220 may reside. A latch 210 forms a cover over the needle 220.

An arcuate suturing needle 220 having a sharp, pointed end 224 isslidably mounted in a circular track 192 of the needle holder assembly188. The blunt end of the needle 226 is connected to the suturingmaterial or thread 246. The needle 220 normally resides in a “home”position in the track 192 such that the gap in the arcuate suturingneedle 222 is in alignment with an aperture 218 in the needle holderassembly 188. The sharp, pointed end of the needle 224 is situated onone side and entirely within the confines of the needle holder aperture218; the pointed end of the needle 224 is, therefore, shielded by theneedle holder assembly 188. The blunt end of the suturing needle 226that is attached to the suturing material or thread 246 is located atthe opposite side of the aperture 218. The sharp, pointed end of theneedle 224 is, therefore, wholly contained within the needle holderassembly 188 and does not protrude beyond the housing of the needleholder assembly 188. Thus, the sharp pointed end of the needle 224 isnot exposed to the user.

In accordance with the presently disclosed embodiments, the needle 220may be releasably engaged by the needle driver 198 that is rotatablymounted within the suture head assembly 156 so that the needle 220 canbe rotated from the home position by about 360 degrees about the centralvertical axis of the needle holder assembly 188. Such a rotary action ofthe needle 220 causes the sharp point 224 to advance across the needleholder assembly 188 so as to span the aperture 218. Thus, when thedevice 150 is positioned such that the incised tissue segments to besutured are situated at the needle holder assembly aperture 218, theneedle 220 penetrates the tissue segments and spans the incision betweenthem. A continued rotary movement of the needle 220 causes the needle220 to return to the home position, and thereby causes the suturingmaterial or thread 246 attached to the needle 220 to be pulled into andthrough the tissue in an inward direction on one side of the tissueincision, and upwards and out through the tissue on the opposite side ofthe incision. Thus, the suture material or thread 246 follows the curvedpath of the needle 220 to bind the tissues together with a stitch ofmaterial or thread 246 across the incision in a manner similar to manualsuturing, wherein the needle 220 is “pushed” from the blunt end 226 andthen “pulled” from the pointed end 224 by the pawl 198. Preferably, ananchoring mechanism is provided at the trailing terminal end of thesuturing material or thread 246 to prevent the material 246 from beingpulled completely through and out of the tissue segments. For example,the anchoring mechanism can be a pre-tied or a welded loop, a knotwherein the suture material or thread 246 is simply tied, or adouble-stranded, looped suture is that attached to the suturing needle220. The rotary movement of the needle 220 within the needle holderassembly 188 is accomplished by a pawl 198 that may be operated by theuser by holding the suturing device 150 with one hand in a pistol-likegrip around the handle 160, and using at least one finger of that handto activate.

In accordance with further aspects of the invention, for purposes ofillustration and not limitation, FIGS. 61-71 depict a further embodimentof a suturing head 500 for a suturing instrument.

FIGS. 61-62 illustrate perspective views of this embodiment, both inplain view and showing hidden features, respectively. As illustrated,suturing head 500 is comprised of two main housing components, 502 and504. Housing component 502 defines a portion of a needle track 506 thatis complete when components 502, 504 are assembled. This embodiment issimilar to that of FIG. 39, but with certain differences. Significantly,in contrast to the embodiment of FIG. 39, this embodiment operates bymoving needle 520 through needle track 506 during a pull stroke offilament 530, rather than during a push stroke. Distal end 534 offilament 530 is attached to an engagement mechanism 550 that selectivelyengages notches formed in the needle 520 in a manner similar to otherembodiments described herein. As depicted in FIG. 63, engagementmechanism rides in an arcuate track 505 formed in housing component 504that is generally concentric with the needle track 506. Suturing head500 includes a tissue capture gap 540, similar to the embodiment of FIG.39.

FIG. 65 depicts the engagement mechanism that rides in track 505. Asdepicted, engagement mechanism 550 includes four main components: cap552, sleeve 554, piston 556 and a chamber 558 housing a compressionspring 559 (spring 559 is depicted in FIG. 67(B)). In operation, sleeve554 is affixed to distal end 534 of filament 530, piston 556 is receivedwithin sleeve 554. Next spring 559 is inserted into cap 552, which inturn is attached to sleeve 554. Reduced diameter portion 556 a of piston556 is urged through bore 554 a of sleeve 554. Portion 556 a of piston556 mates with notches 526, 528 in needle 520. The operation of suturinghead 500 through a complete cycle will now be described.

As depicted in FIG. 66, needle 520 having a first pointed end 522 and asecond end 524 is in the home position prior to a rotation cycle, andengagement mechanism 550 is engaged with notch 528 in needle 520. Asdepicted, needle includes a hollow 529 in second end 524 of needle 520for receiving a suture (not shown). Filament 530 further includes anenlarged portion 535 for riding against needle track 506 to reducefriction and ease operation of the suturing head. As further depicted,tip 562 of pawl 560 is biased to engage with antirotate notch 527 formedinto the outer circumferential surface of needle 527.

As depicted in FIG. 67(A), filament 530 is pulled proximally through thesuturing instrument, causing engagement mechanism 550 to urge againstnotch 528 in needle, resulting in needle 520 being drawn through track506, across gap 540, and back into track 506. Tip 562 of pawl 560 slidesout of antirotate notch 527 of needle 520 and drags along the needle 520as needle 520 moves through needle track 506. As can be seen in sidecross-sectional view FIG. 67(B), end 556 a of piston 556 is urgedagainst notch 528 of needle 520 by spring 559. FIG. 68 depicts needle520 after having been moved through a 180 degree rotation. As can beseen in FIG. 68, second end 524 of needle has moved past tip 562 of pawl560, and tip 562 of pawl snaps into the needle track 506 to prevent theneedle 520 from reversing direction. At this point, filament 530 is onceagain advanced distally, causing tip 556 a of piston 556 to urge againstthe distal inclined surface 528 a of notch 528. Inclined surface 528 aacts as a ramp to push piston 556 into chamber 558 against the force ofspring 559 until surface 556 a rides up out of notch 528, and over theouter surface of needle 520 through track 505 until it passes overneedle 520 and pops back out. As engagement mechanism 550 continues tobe guided by arcuate notch 505, it encounters first end 522 of needle520. The pointed end 522 of needle 520 once again acts as a ramp,compressing spring 559 as surface 556 a rides up and over the needle 520until surface 556 a reaches notch 526. Upon reaching the notch 526, thepiston snaps down into the notch. At this position, engagement mechanismis as depicted in FIG. 69.

Next, filament 530 is once again pulled proximally through devicecausing the needle 520 to move through another 180 degree rotation,returning the needle 520 to the home position as depicted in FIGS.70(A)-70(B). While antirotate notch 527 can move past tip 562 of pawl560, when filament 530 is moved distally once again to pick up theneedle at notch 528, needle 520 will move backward slightly until notch527 engages with pawl tip 562. At that point, surface 556 a ofengagement mechanism 550 rides up inclined surface 526 a and travelsover the outer lateral surface of the needle 520 until the piston snapsinto notch 528, preparing the suturing head 500 for another cycle asdepicted in FIGS. 71(A)-71(B).

Suturing head 520 can be constructed using any desired techniques andany desired materials as described herein, for example, with referenceto suturing head 356. Preferably, suturing head 500 is made from apolymeric material to permit manufacture of a low-cost, disposabledevice. Suturing head 500 can be mounted on a flexible shaft as depictedin FIG. 39(B).

In accordance with still further aspects of the invention, for purposesof further illustration and not limitation, FIGS. 72-85 depict furthervariations of the device generally depicted at FIGS. 1-38.

As depicted in FIG. 72, device 600 is provided with a handle 660 thathas been found to be particularly user-friendly and comfortable. Device600 also includes a suturing head 610, an elongate tubular body 640, andan roticulation region 650.

The roticulation region 650 is illustrated in FIG. 73. Roticulationsection includes a hub 652 that is attached to tubular body 640. Hub 652is rotatably mounted on a cylindrical bearing surface 658, having aplurality of elongate detents 659 surrounding the bearing surface 658. Adetent ball 654 is contained within a detent housing 655, wherein aspring 656 urges detent ball 656 into a detent 659, preventing the hubfrom rotating freely, but also permitting hub to be rotated(“roticulated”) about the axis of device 600, thereby permittingroticulation of the suturing head 610.

As with the suturing head depicted, for example, in FIGS. 30-31, a latch612 is also provided in the embodiment of FIG. 72 to cover the suturingneedle. Specifically, as depicted in FIGS. 74-76, latch 612 is provided,and is preferably biased (e.g., by a spring) to the closed position.While latch 612 can be retracted proximally by pushing on the latch 612itself, during a procedure latch 612 may not be easily accessible. Thus,if the device 600 should jam, to avoid the difficulty in moving thelatch backward to permit the needle to fall out of device, a pull wire616 is provided that is attached at its distal end to the latch 612(inside of a bore 614), and at its proximal end to a release trigger 618that pivots about a point 618 a. Thus, if it is desired to retract thelatch 612 to permit the needle to fall out in the event of a jam, it canbe released, the device 600 can be withdrawn, and the needle can beremoved with forceps. The device 600 can then be reused with a newneedle.

FIGS. 77-83 depict an alternative drive mechanism for the suturing head610. Specifically, all components of the drive mechanism are fitted toone side of the suturing head 610 a, rather than being anchored to bothsides of the suturing head 610. This is very advantageous in assembly.Specifically, all drive components (pulleys and the like) are attachedto side 610 a of the suturing head. This prevents any inconvenience inneeding to align the pulleys and other drive components with twoopposing housing sections, and facilitates assembly generally as thisdesign permits the drive components to be stacked and attached to asingle member. As will be noted, the drive components bear somesimilarity to those depicted in FIGS. 34-35. A drive cable 634 is routedaround a drive idler 624, and into the drive pulley 620 a. Drive pulley620 a, in turn, drives an idler pulley 621 by way of an actuator arm 628when advancing the suturing needle. A link or strut 622 is provided thatacts as a stop for rotation of pulley 621 by engaging a bearing surface621 b in groove 621 a. A needle engagement mechanism/needle assemblyextension 628 a is provided for driving the suturing needle (notdepicted). In addition, a return cable 636 is routed around a returnidler 626, and into the return pulley 620 b, which is concentric withthe drive pulley 620 a. Return pulley 620 b, in turn, drives idlerpulley 621 by way of actuator arm 628 in a direction opposite from thedrive pulley 620 a, causing engagement mechanism 628 a to return to thehome position to repeat the half cycle. FIGS. 84-85 depict crosssectional and three dimensional wireframe views of the handle portion660 of device 600, respectively, depicting, for example, actuator handle662 as well as the arrangement of interior passages through which driveand return cables are routed. The return cable 636 is preferablyspring-loaded so as to cause the needle engagement mechanism 628 a toreturn to its home position.

The suturing devices of the presently disclosed embodiments can be usedfor laparoscopic procedures, including but not limited to laparoscopiccolostomy, colectomy, adrenalectomy, splenectomy, repair ofparaesophageal hernia, inguinal hernia repair, ventral hernia repair.Nissen fundoplication, liver lobectomy, gastrectomy, small bowelresection, treatment of small bowel obstruction, distal pancreatectomy,nephrectomy and gastric bypass. Those skilled in the art will recognizethat the presently disclosed embodiments can be used in otherlaparoscopic procedures.

In using the device 150 of the presently disclosed embodiments, theabdomen is insufflated with gas to create a working space for the user.Any gas known to those skilled in the art including, but not limited to,nitrogen or carbon dioxide, can be used. Access portals are establishedusing trocars in locations to suit the particular surgical procedure. Avariety of surgical instruments may then be inserted into the bodythrough these access ports/cannulas. The user then introduces the distalend portion of suturing device 150 into a cannula, and then laterallyarticulates the suture head assembly 156 using the articulation lever166 located just distal to the top of the handle 160. The suture headassembly 156 is then positioned relative to the tissue/vessel to besutured together, and the user locks the suture head assembly 156 inplace using the locking lever 164. The user then, through manipulationof the suturing device 150, positions a plurality of separated tissuesegments into the opening defined at the distal end portion of thesuture head assembly 156 and within the aperture 218 of the needleholder assembly 188. The user, using only one hand, may manipulate thedevice 150 while actuating the handle 160 to close an incision with acontinuous suture whose stitches may be individually tensioned preciselyand uniformly along the length of the suture similar to suturing done byhand in the conventional way. The user may employ a single suture whichwould extend the entire length of the incision or multiple sutures.Thus, by placement of the device 150 with the needle holder assemblyaperture 218 spanning the incised tissue segments and actuating thehandle 160, the suturing device 150 enables the user to lay down arunning stitch or interrupted stitch to close the tissue incision in atime efficient manner. Those skilled in the art will recognize that anyconventional procedure for conducting laparoscopic surgery can be usedwith the device 150.

The minimalized structural design of the suture head assembly 156enables the user to have a clear, unobstructed view of the suturingneedle 220 during advancement through the tissue segments during thecourse of a suturing operation, thereby enabling precise placement ofthe suturing device 150 to provide uniform sutures and precluding therisk of tearing tissue by placement too close to the edge of theincision. The suturing device 150 is then advanced a short distancealong the incision and the aforementioned operation is repeated toproduce another stitch comprising the suturing material or thread 246.

The user may continue to manipulate the suturing device 150, alternatelyadvancing and actuating rotation of the needle 220 about an axis that isgenerally parallel to the direction of advancement to create acontinuous suture which may extend through the entire length of theincision or a series of interrupted stitches. After each individualstitch is laid down, the stitch is tightened by exerting a pull on thesuturing material or thread 246 so that the resultant suture istensioned uniformly along the length of the incised tissue segments.Therefore, a tight closure of the segments is accomplished and bleedingand tearing of tissue are minimized. Once the appropriate amount ofsuture material or thread 246 has been placed, the user can use a needlegrasper to tighten and knot the formed stitches.

The suturing device 150 may be configured in different ways with respectto length and angle of the suture head assembly 156. The size of theneedle 220, the needle holder assembly 188, the needle holder aperture218 and the aperture position may also be varied for use in open surgeryto perform procedures such as closing of the fascia, skin closure, softtissue attachment, anastomosis, fixation of mesh, grafts and otherartificial materials. Moreover, devices made in accordance with theteachings herein can be used in combination with needle loader devicesdescribed, for example, in U.S. patent application Ser. No. 12/175,442,filed Jul. 17, 2008.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that various of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or applications. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art which arealso intended to be encompassed by the present disclosure.

1. A suturing device comprising a suturing head, the suturing headcomprising: a) a needle track housing portion including a needledisposed in a needle track, the needle track being adapted andconfigured to guide the needle along a curved path about an axis ofrotation substantially perpendicular to a longitudinal axis of thesuturing head, the needle having: i) a curved body, the curved bodycovering an arc greater than about 180°; and ii) an engagement surfacefor driving the needle; and b) a drive housing portion containing adrive, wherein the drive includes an elongate flexible member, at leasta portion of the elongate flexible member being adapted and configuredto reciprocate along and direction substantially parallel to thelongitudinal axis, the elongate flexible member being further adaptedand configured to engage the engagement surface of the needle andadvance the needle through a circular arc as the elongate flexiblemember is advanced along the longitudinal axis in a proximal direction.